TB Research

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

Antonio Lombardi, MD

Abstract

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

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.

MeSH terms

  • Tuberculosis, Multidrug-Resistant
  • Extensively Drug-Resistant Tuberculosis