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

NCT ID: NCT04881955

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2021-09-07

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 Male Subjects.

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 prior to dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until at least Day 8 (Discharge). On Day 1, subjects will receive a single oral dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of [14C]-ecopipam HCl. Subjects will be discharged when the following discharge criteria are met:

• plasma radioactivity levels below the limit of quantitation for 2 consecutive collections;
• ≥ 90% mass balance recovery; and
• ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which collections occur. If discharge criteria are not met on Day 8, subjects will remain in the CRU and additional 24-hour collections (blood, urine, and feces) for total radioactivity will continue until these criteria are met, up to a maximum of Day 15.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]-Ecopipam

Single oral capsule dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of \[14C\]-ecopipam HCl

Group Type: EXPERIMENTAL

[14C]-Ecopipam

Intervention Type: DRUG

\[14C\]-Ecopipam

Interventions

[14C]-Ecopipam

\[14C\]-Ecopipam

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit Ltd.

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

EBS-101-HV-103

Identifier Type: -

Identifier Source: org_study_id