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OpenTrials
Completed

NCT Number: NCT05334108

Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

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Key information

Conditions

Drug Interaction

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

About this study

Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects or female subjects of non-childbearing potential
  • ≥18 and <55 years of age at the time of consent
  • BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
  • Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
  • Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
  • Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion criteria

  • Personal or family History of significant medical illness
  • Clinically significant abnormalities on screening tests/exams
  • History of or significant risk of committing suicide
  • Donation of plasma within 7 days prior to dosing
  • Donation or significant loss of blood within 30 days prior to the first dosing
  • Major surgery within 3 months or minor surgery within 1 month prior to admission
  • Use of prohibited prescription, over-the-counter medications or natural health products
  • Alcohol-based products 24 hours prior to admission
  • Female subjects who are currently pregnant or lactating
  • Positive pregnancy test
  • Use of tobacco or nicotine products within 3 months prior to Screening
  • Significant alcohol consumption
  • History of drug abuse within the previous 2 years, or a positive drug screen
  • History of allergy to study medications
  • Undergoing abrupt discontinuation of alcohol or sedatives
  • Not suitable for study in the opinion of the Principal Investigator

Treatment and study plan

Ecopipam

Drug

ecopipam HCl ~2mg/kg/day

Cohort 1 Probe Substrate Cocktail

Combination Product

dextromethorphan, caffeine, omeprazole, and midazolam

Cohort 2 Probe Substrate

Drug

bupropion

Cohort 3 Probe Substrate Cocktail

Combination Product

dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

Primary outcomes

  1. Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  2. Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  3. Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  4. Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  5. Cmax of dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  6. Cmax of dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  7. Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  8. Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  9. Cmax of rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  10. Cmax of rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  11. Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  12. Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  13. AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  14. AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  15. AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  16. AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  17. AUCinf of dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  18. AUCinf of dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  19. AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  20. AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  21. AUCinf of rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  22. AUCinf of rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  23. AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  24. AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  25. AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  26. AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  27. AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  28. AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  29. AUClast of dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  30. AUClast of dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  31. AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  32. AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  33. AUClast of rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  34. AUClast of rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  35. AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  36. AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  37. AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  38. AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  39. AUC0-24 of dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  40. AUC0-24 of dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  41. AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  42. AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  43. AUC0-24 of rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  44. AUC0-24 of rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  45. AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  46. AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Secondary outcomes

  1. Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  2. Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  3. Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  4. Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  5. AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  6. AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  7. AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  8. AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  9. AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  10. AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  11. AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  12. AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  13. CL/F for dextromethorphan in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  14. CL/F for dextromethorphan in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  15. CL for IV midazolam in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  16. CL for IV midazolam in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  17. CL/F for oral midazolam in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  18. CL/F for oral midazolam in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  19. CL/F for dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  20. CL/F for dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  21. CL/F for pitavastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  22. CL/F for pitavastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  23. CL/F for rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  24. CL/F for rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  25. CL/F for atorvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  26. CL/F for atorvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  27. CL/F for bupropion in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  28. CL/F for bupropion in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  29. CL/F for caffeine in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  30. CL/F for caffeine in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  31. CL/F for omeprazole in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  32. CL/F for omeprazole in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  33. V/F for dextromethorphan in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  34. V/F for dextromethorphan in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  35. V for IV midazolam in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  36. V for IV midazolam in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  37. V/F for oral midazolam in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  38. V/F for oral midazolam in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  39. V/F for dabigatran in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  40. V/F for dabigatran in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  41. V/F for pitavastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  42. V/F for pitavastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  43. V/F for rosuvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  44. V/F for rosuvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  45. V/F for bupropion in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  46. V/F for bupropion in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  47. V/F for atorvastatin in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  48. V/F for atorvastatin in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  49. V/F for caffeine in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  50. V/F for caffeine in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  51. V/F for omeprazole in the presence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  52. V/F for omeprazole in the absence of ecopipam

    Time frame: Up to Day 22

    Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  53. Total concentration of bilirubin in the presence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  54. Total concentration of bilirubin in the absence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  55. Unconjugated concentration of bilirubin in the presence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  56. Unconjugated concentration of bilirubin in the absence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  57. Conjugated concentration of bilirubin in the presence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  58. Conjugated concentration of bilirubin in the absence of ecopipam

    Time frame: Up to Day 18

    Bilirubin sampling will occur on Day 1 and Day 18

  59. Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  60. Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  61. Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  62. Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  63. Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  64. Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  65. Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  66. Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  67. Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  68. Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  69. Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  70. Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam

    Time frame: Up to Day 14

    6 blood samples will be collected at the indicated time points for pharmacokinetic analysis

  71. Safety and tolerability as demonstrated by the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)

    Time frame: Up to Day 63

    Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints

  72. Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 63

    Safety and tolerability measures will be recorded at the indicated timepoints

  73. Number of participants requiring concomitant medications

    Time frame: Up to Day 63

    Participants will be continuously monitored for the use of concomitant medications

  74. AEs with relatedness associated with dextromethorphan

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  75. AEs with relatedness associated with IV midazolam

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  76. AEs with relatedness associated with oral midazolam

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  77. AEs with relatedness associated with dabigatran

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  78. AEs with relatedness associated with pitavastatin

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  79. AEs with relatedness associated with rosuvastatin

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  80. AEs with relatedness associated with atorvastatin

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  81. AEs with relatedness associated with bupropion

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  82. AEs with relatedness associated with caffeine

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  83. AEs with relatedness associated with omeprazole

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  84. AEs with relatedness associated with ecopipam

    Time frame: Up to Day 63

    Subjects will be continually monitored for adverse events

  85. Absolute values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  86. Absolute values of hematocrit (percent)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  87. Absolute values of hemoglobin (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  88. Absolute values of Red blood cell (RBC) count (M/mm3)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  89. Absolute values of sodium, potassium, chloride (mmol/L)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  90. Absolute values of magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  91. Absolute values of albumin and total protein (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  92. Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatinine phosphokinase (CPK), and creatinine (U/L)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  93. Absolute values of urine specific gravity

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  94. Absolute values of urine pH

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  95. Absolute values of urine glucose

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  96. Absolute values of urine protein

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  97. Absolute values of urine blood

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  98. Absolute values of urine ketones

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  99. Absolute values of urine bilirubin and nitrite

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  100. Absolute values of urobilinogen (Eu/dL)

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  101. Absolute values of urine leukocytes by dipstick

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  102. Change from Day -1 to Day of Discharge white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  103. Change from Day -1 to Day of Discharge in hematocrit (percent)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  104. Change from Day -1 to Day of Discharge in hemoglobin (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  105. Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/mm3)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  106. Change from Day -1 to Day of Discharge in sodium, potassium, chloride (mmol/L)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  107. Change from Day -1 to Day of Discharge in magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  108. Change from Day -1 to Day of Discharge in albumin and total protein (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  109. Change from Day -1 to Day of Discharge in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK), and creatinine (U/L)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of clinical chemistry parameters

  110. Change from Day -1 to Day of Discharge in urine specific gravity

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  111. Change from Day -1 to Day of Discharge in urine pH

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  112. Change from Day -1 to Day of Discharge in urine glucose

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  113. Change from Day -1 to Day of Discharge in urine protein

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  114. Change from Day -1 to Day of Discharge in urine blood

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  115. Change from Day -1 to Day of Discharge in urine ketones

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  116. Change from Day -1 to Day of Discharge in urine bilirubin and nitrite

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  117. Change from Day -1 to Day of Discharge in urobilinogen (Eu/dL)

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  118. Change from Day -1 to Day of Discharge in urine leukocytes by dipstick

    Time frame: Up to Day 26

    Urine samples will be collected for the assessment of urine parameters

  119. Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)

    Time frame: Up to Day 26

    Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured

  120. Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds)

    Time frame: Up to Day 26

    Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured

  121. Absolute values of oral temperature (degrees Celsius)

    Time frame: Up to Day 26

    Temperature will be assessed as part of vital signs

  122. Change from pre-dose for the respective day in oral temperature (degrees Celsius)

    Time frame: Up to Day 26

    Temperature will be assessed as part of vital signs

  123. Absolute values of heart rate (beats/minute)

    Time frame: Up to Day 26

    Heart rate will be assessed as part of vital signs

  124. Change from pre-dose for the respective day in heart rate (beats/minute)

    Time frame: Up to Day 26

    Heart rate will be assessed as part of vital signs

  125. Absolute values of respiratory rate (breaths/minute)

    Time frame: Up to Day 26

    Respiratory rate will be assessed as part of vital signs

  126. Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)

    Time frame: Up to Day 26

    Blood pressure will be assessed as part of vital signs

  127. Change from pre-dose for the respective day in SBP and DBP (mmHG)

    Time frame: Up to Day 26

    Blood pressure will be assessed as part of vital signs

  128. Absolute values of mean corpuscular hemoglobin (MCH) (pg)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  129. Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin (MCH) (pg)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  130. Absolute values of mean corpuscular volume (MCV) (fL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  131. Change from Day 1 to Day of Discharge of mean corpuscular volume (MCV) (fL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  132. Absolute values of mean corpuscular hemoglobin concentration (MCHC) (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

  133. Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin concentration (MCHC) (g/dL)

    Time frame: Up to Day 26

    Blood samples will be collected for the assessment of hematology parameters

Sponsors and collaborators

Lead sponsor

Emalex Biosciences Inc.

Industry

Collaborators

  • ICON plc
  • Nuventra, Inc.

Registry information

Official study title

A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Repeat Titrated Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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