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

NCT03202693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-08-02

No results posted yet for this study

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

Interventions

DRUG

PA-824

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • William Bridson, MD · Covance CRU

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202693 on ClinicalTrials.gov