Status:
COMPLETED
Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects
Lead Sponsor:
Emalex Biosciences Inc.
Collaborating Sponsors:
Covance
Conditions:
Healthy Volunteer
Eligibility:
MALE
35-55 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This study will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 29 days p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04881955
Start Date
May 12 2021
End Date
September 7 2021
Last Update
December 3 2021
Active Locations (1)
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1
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH