Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite

• Status: Completed
• Trial end date: 2021-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Collaborators: Nuventra; Syneos Health
• Treatments: Ecopipam; Mefenamic Acid; Valproic Acid

Criteria

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

• 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

• 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

• Not suitable for study in the opinion of the Principal Investigator