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OpenTrials
Completed

NCT Number: NCT06194864

Drug Interaction Study

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) 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

Syneos Health Clinic Inc.

Québec, Quebec, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male subjects or femail subjects of non-childbearing potential
  • ≥18 and ≤55 years of age
  • BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
  • Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, 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.
  • Willing to take off dentures or mouth piercing at the time of dosing.

Exclusion criteria

  • 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 8 weeks 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
  • Female subjects who are currently pregnant or lactating
  • Positive pregnancy test
  • Positive urine drug screen, urine cotinine test, or alcohol breath test
  • Use of tobacco or nicotine products within 1 month prior to Screening
  • Significant alcohol consumption
  • History of drug abuse within the previous year, or a positive drug screen
  • History of allergy to study medications
  • Part 1 only: Presence of orthodontic braces or orthodontic retention wires
  • Recent participation in a clinical research study
  • Not suitable for study in the opinion of the Principal Investigator

Treatment and study plan

Itraconazole

Drug

itraconazole 200 mg QD Days 6 to 16

rifampicin

Drug

rifampicin 600 mg QD Days 6 to 20

Ecopipam

Drug

89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2

Primary outcomes

  1. AUC0-inf of ecopipam when administered with itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  2. AUC0-inf of ecopipam when administered without itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  3. AUC0-inf of ecopipam when administered with rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  4. AUC0-inf of ecopipam when administered without rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  5. AUC0-t of ecopipam when administered with itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  6. AUC0-t of ecopipam when administered without itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  7. AUC0-t of ecopipam when administered with rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  8. AUC0-t of ecopipam when administered without rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  9. Cmax of ecopipam when administered with itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  10. Cmax of ecopipam when administered without itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  11. Cmax of ecopipam when administered with rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  12. Cmax of ecopipam when administered without rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  13. T½ el of ecopipam when administered with itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  14. T½ el of ecopipam when administered without itraconazole

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  15. T½ el of ecopipam when administered with rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  16. T½ el of ecopipam when administered without rifampicin

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

Secondary outcomes

  1. AUC0-inf of EBS-101-40853

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  2. AUC0-inf of ecopipam glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  3. AUC0-inf of EBS-101-40853 glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  4. AUC0-t of EBS-101-40853

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  5. AUC0-t of ecopipam glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  6. AUC0-t of EBS-101-40853 glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  7. Cmax of EBS-101-40853

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  8. Cmax of ecopipam glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  9. Cmax of EBS-101-40853 glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  10. T½ el of EBS-101-40853

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  11. T½ el of ecopipam glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  12. T½ el of EBS-101-40853 glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  13. AUC0-4 for ecopipam

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  14. AUC0-4 for EBS-101-40853

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  15. AUC0-4 for ecopipam glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  16. AUC0-4 for EBS 101-40853 glucuronide

    Time frame: Up to Day 21

    Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis

  17. Minimum Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score

    Time frame: Up to Day 21

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

  18. AUEC for Visual Analogue Scale (VAS)

    Time frame: Up to Day 21

    Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.

  19. Maximum sedation for Visual Analogue Scale (VAS)

    Time frame: Up to Day 21

    Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints.

  20. AUEC for Reaction Time Index (RTI) score

    Time frame: Up to Day 21

    Reaction time for subject to release the response button after presentation of target stimulus.

  21. Maximum sedation for Reaction Time Index (RTI) score

    Time frame: Up to Day 21

    Reaction time for subject to release the response button after presentation of target stimulus.

  22. Safety and tolerability as demonstrated by AEs with itraconazole

    Time frame: Up to Day 30

    Subjects will be continually monitored for adverse events

  23. Safety and tolerability as demonstrated by AEs without itraconazole

    Time frame: Up to Day 30

    Subjects will be continually monitored for adverse events

  24. Safety and tolerability as demonstrated by AEs with rifampicin

    Time frame: Up to Day 30

    Subjects will be continually monitored for adverse events

  25. Safety and tolerability as demonstrated by AEs without rifampicin

    Time frame: Up to Day 30

    Subjects will be continually monitored for adverse events

  26. Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with itraconazole (mmHG)

    Time frame: Up to Day 21

    Blood pressure will be assessed as part of vital signs

  27. Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without itraconazole(mmHG)

    Time frame: Up to Day 21

    Blood pressure will be assessed as part of vital signs

  28. Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with rifampicin(mmHG)

    Time frame: Up to Day 21

    Blood pressure will be assessed as part of vital signs

  29. Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without rifampicin(mmHG)

    Time frame: Up to Day 21

    Blood pressure will be assessed as part of vital signs

  30. Heart rate with itraconazole (beats/minute)

    Time frame: Up to Day 21

    Heart rate will be assessed as part of vital signs

  31. Heart rate without itraconazole (beats/minute)

    Time frame: Up to Day 21

    Heart rate will be assessed as part of vital signs

  32. Heart rate with rifampicin (beats/minute)

    Time frame: Up to Day 21

    Heart rate will be assessed as part of vital signs

  33. Heart rate without rifampicin (beats/minute)

    Time frame: Up to Day 21

    Heart rate will be assessed as part of vital signs

  34. Respiratory rate pressure with itraconazole (breaths/minute)

    Time frame: Up to Day 21

    Respiratory rate will be assessed as part of vital signs

  35. Respiratory rate without itraconazole (breaths/minute)

    Time frame: Up to Day 21

    Respiratory rate will be assessed as part of vital signs

  36. Respiratory rate with rifampicin (breaths/minute)

    Time frame: Up to Day 21

    Respiratory rate will be assessed as part of vital signs

  37. Respiratory rate without rifampicin (breaths/minute)

    Time frame: Up to Day 21

    Respiratory rate will be assessed as part of vital signs

  38. Oral temperature with itraconazole (degrees Celsius)

    Time frame: Up to Day 21

    Temperature will be assessed as part of vital signs

  39. Oral temperature without itraconazole (degrees Celsius)

    Time frame: Up to Day 21

    Temperature will be assessed as part of vital signs

  40. Oral temperature with rifampicin (degrees Celsius)

    Time frame: Up to Day 21

    Temperature will be assessed as part of vital signs

  41. Oral temperature without rifampicin (degrees Celsius)

    Time frame: Up to Day 21

    Temperature will be assessed as part of vital signs

  42. Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with itraconazole (Milliseconds)

    Time frame: Up to Day 21

    Twelve-lead ECGs will be obtained at the indicated timepoints

  43. Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without itraconazole (Milliseconds)

    Time frame: Up to Day 21

    Twelve-lead ECGs will be obtained at the indicated timepoints

  44. Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with rifampicin (Milliseconds)

    Time frame: Up to Day 21

    Twelve-lead ECGs will be obtained at the indicated timepoints

  45. Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without rifampicin (Milliseconds)

    Time frame: Up to Day 21

    Twelve-lead ECGs will be obtained at the indicated timepoints

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

    Time frame: Up to Day 21

    C-SSRS to be administered at the indicated timepoints

  47. Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)

    Time frame: Up to Day 21

    Blood samples will be collected for the assessment of hematology parameters

  48. Value of hematocrit (percent)

    Time frame: Up to Day 21

    Blood samples will be collected for the assessment of hematology parameters

  49. Value of hemoglobin (g/dL)

    Time frame: Up to Day 21

    Blood samples will be collected for the assessment of hematology parameters

  50. Red blood cell (RBC) count (M/mm3)

    Time frame: Up to Day 21

    Blood samples will be collected for the assessment of hematology parameters

  51. Values of sodium, potassium, chloride (mmol/L)

    Time frame: Up to Day 21

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

  52. Values of urea, phosphorus, calcium, glucose, and total, direct and indirect bilirubin (mg/dL)

    Time frame: Up to Day 21

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

  53. Values of albumin and total protein (g/dL)

    Time frame: Up to Day 21

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

  54. Values of alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatininephosphokinase (CPK), and creatinine (U/L)

    Time frame: Up to Day 21

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

  55. Values of urine specific gravity

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  56. Values of urine pH

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  57. Values of urine glucose

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  58. Values of urine protein

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  59. Values of urine blood

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  60. Values of urine ketones

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  61. Values of urine bilirubin and nitrite

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  62. Values of urobilinogen

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

  63. Values of urine leukocyte esterase by dipstick

    Time frame: Up to Day 21

    Urine samples will be collected for the assessment of urine parameters

Sponsors and collaborators

Lead sponsor

Emalex Biosciences Inc.

Industry

Collaborators

  • Cambridge Cognition Ltd
  • Syneos Health

Registry information

Official study title

A Phase 1, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2024
Registry last updated
Sep 19, 2024

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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