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Completed

NCT Number: NCT06669091

Food-effect Study of Ecopipam Pharmacokinetics

Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.

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Key information

Conditions

Food-effect

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

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
  • 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.

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 1 month 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
  • Use of tobacco or nicotine products within 1 month prior to Screening
  • Significant alcohol consumption or history of abuse
  • History of drug abuse within the previous 2 years, or a positive drug screen
  • History of cannabinoid use within the previous 3 months
  • Positive urine drug screen, urine cotinine test, or alcohol breath test
  • History of allergy to study medications
  • Recent participation in a clinical research study
  • Prior exposure to ecopipam
  • Not suitable for study in the opinion of the Principal Investigator

Treatment and study plan

Ecopipam tablet

Drug

A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg)

Primary outcomes

  1. Cmax of ecopipam after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  2. Tmax of ecopipam after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  3. AUC of ecopipam after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  4. AUCinf of ecopipam after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  5. AUClast of ecopipam after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  6. Cmax of ecopipam after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  7. Tmax of ecopipam after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  8. AUC of ecopipam after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  9. AUClast of ecopipam after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  10. AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

Secondary outcomes

  1. Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  2. Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  3. AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  4. AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  5. Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  6. Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  7. AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  8. AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  9. Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  10. Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  11. AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  12. AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  13. Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  14. Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  15. AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  16. AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  17. Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  18. Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  19. AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  20. AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  21. Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  22. Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  23. AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  24. AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state

    Time frame: Up to Day 13

    Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis

  25. Safety and tolerability as demonstrated by concomitant medications

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  26. Safety and tolerability as demonstrated by physical exams

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  27. Safety and tolerability as demonstrated by AEs

    Time frame: Up to Day 20

    Subjects will be continually monitored for adverse events

  28. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  29. Respiratory rate (breaths/minute)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  30. Oral temperature (degrees Celsius)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

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

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

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

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  33. Value of hematocrit (percent)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  34. Value of hemoglobin (g/dL)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

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

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  36. Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  37. Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

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

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  39. Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L)

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  40. Value of urine pH

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  41. Value of urine glucose

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  42. Value of urine protein

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  43. Value of urine blood

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

  44. Value of urine leukocyte esterase by dipstick

    Time frame: Up to Day 20

    Safety and tolerability measures will be recorded at the indicated timepoints

Sponsors and collaborators

Lead sponsor

Emalex Biosciences Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, 2-way Crossover, Food-effect Study of Ecopipam Pharmacokinetics After Administration of the to Be Marketed Tablet in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Jan 27, 2025

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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