Drug Interaction Study

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Collaborators: Cambridge Cognition Ltd; Syneos Health
• Treatments: Ecopipam; Itraconazole; Rifampin

Criteria

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