drugset / Trial / NCT03202693

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

NCT03202693

Phase 1 Completed 6 enrolled Global Alliance for TB Drug Development
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-03
Primary completion
2006-05
Completion
2006-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pretomanid Small molecule 1000 mg Oral

Indications