NCT04881955

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	[14C]-Ecopipam	\[14C\]-Ecopipam

Timeline

• Start date: 2021-05-12
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2021-05-11
• Last updated: 2021-12-03

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study