Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in healthy adult male subjects to assess the absorption, metabolism, and excretion of [14C]-Ecopipam in Healthy Male Subjects.

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

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Collaborator: Covance
• Treatments: Ecopipam

Criteria

Inclusion Criteria:

• Males of any race between 35 and 55 years of age

• Body mass index between 18.0 and 30.0 kg/m2

• In good health

• Males will agree to use contraception

• Able to comprehend and sign an informed consent form

• History of a minimum of 1 bowel movement per day

Exclusion Criteria:

• History of significant medical illness

• History of clinically significant drug allergy

• History of a seizure disorder, not including infantile seizures

• History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs

• Clinically significant medical treatment within 8 weeks or infection treatment within 4 weeks of dosing

• Clinically significant ECG abnormality

• History of alcoholism or drug/chemical abuse within the previous 2 years or positive screening test

• Significant alcohol consumption

• Positive hepatitis panel and/or positive human immunodeficiency virus test

• Use of prohibited prescription, over-the-counter medications or natural health products

• Use of tobacco or nicotine-containing products within 3 months prior to Check-in or positive screening test

• Receipt of blood products within 2 months prior to Check in

• Recent donation of blood, plasma, or platelets prior to Screening

• Exposure to significant diagnostic, therapeutic or employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in

• Evidence or history of active suicidal thoughts in the previous 5 years or have any lifetime history of a suicide attempt

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