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

Healthy Volunteer Clinical Trial

Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam Following a Single Oral Capsule Dose in Healthy Male Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT04881955
• Study type: Interventional
• Source: Emalex Biosciences Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 12, 2021
• Completion date: September 7, 2021