NCT01768273

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

A Phase 1, Open-label, Multi-Dose Study to Assess Pharmacokinetic Interaction Between PA-824 and Midazolam

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of midazolam, a known CYP3A substrate.

Detailed description

This study is an open-label, fixed sequence design. 14 subjects will receive a single dose of 2 mg midazolam, followed by a 2-day wash-out. Following the wash-out, all subjects will receive PA-824 once daily for 14 days. All patients will receive a single dose of 2 mg midazolam on the 14th day of PA-824 dosing. This study will evaluate 400 mg PA-824.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Midazolam
DRUG	PA-824

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2013-01-15
• Last updated: 2019-09-12

Locations

1 site across 1 country: United States