NCT03202693

A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.

A Phase 1, Open-Label, Single-Dose Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of [14C]-PA 824 in Healthy Adult Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of \[14C\] PA-824, and (2) the pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled PA-824 in healthy adult male subjects. Unlabeled PA-824 and \[14C\]-PA-824 will be administered together in an oral-suspension formulation. Enrollment is planned for one dose group of 6 subjects. All 6 subjects will receive the same treatment.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2017-06-28
• Last updated: 2018-08-02

Locations

1 site across 1 country: United States