NCT01828827

Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects

A Phase 1, Randomized, Balanced, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Crossover, Open-Label Study of the Effect of Food on the Bioavailability and Pharmacokinetics of PA-824 Tablets in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. This study was designed to understand the possible effects of a high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be tested in this study is that the rate and extent of absorption of PA-824, as measured by Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824 1000 mg	Two single administrations of 1000mg each administered by 5 tablets of 200mg, one administered in the fed state and one administered in the fasted state.

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2013-04-11
• Last updated: 2016-01-14

Locations

1 site across 1 country: United States