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A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid

Multi-drug Resistant Tuberculosis Clinical Trial

Official title:
An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid

Clinical Trial Summary

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.

Clinical Trial Description

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently. ;

Study Design

Related Conditions & MeSH terms

  • Multi-drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant
Clinical Trial Details
NCT number NCT04309656
Study type Interventional
Source Global Alliance for TB Drug Development
Contact
Status Completed
Phase Phase 1
Start date January 14, 2020
Completion date February 28, 2020
View Details
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