NCT04092712

Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

A Phase 1, Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Oral [14C]-CTP-543 in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of \[14C\]-CTP-543 in healthy male subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-CTP-543	Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution

Timeline

• Start date: 2019-09-05
• Primary completion: 2019-09-11
• Completion: 2019-09-20
• First posted: 2019-09-17
• Last updated: 2019-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study