Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-label, Multi-Dose Study to Assess Pharmacokinetic Interaction Between PA-824 and Midazolam|
- Evaluate the effects of multiple-dose administration of PA-824 on the pharmacokinetics of midazolam, a sensitive probe substrate and representative compound for drugs metabolized by CYP3A enzymes. [ Time Frame: Day 18 ] [ Designated as safety issue: No ]The PK parameters to be calculated for midazolam and 1-hydroxy midazolam include area under the curve [AUC(0-t) and AUC(0-inf)], maximum observed concentration (Cmax), time to maximum observed plasma concentration (Tmax), half-life (t1/2), and apparent terminal elimination rate constant (Kel).
- To evaluate the safety and tolerability of PA-824 when given with midazolam. [ Time Frame: Day 108 ] [ Designated as safety issue: No ]Safety assessments include clinical laboratory assessments, vital signs including respiration rates, electrocardiograms (ECGs), physical examinations, ophthalmology examinations, including visual acuity tests and slit lamp examinations, and monitoring of adverse events (AEs)
|Study Start Date:||December 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Midazolam and 824
2 mg midazolam (oral syrup) Day 1 and Day 17. 400 mg PA-824 once daily Day 4 - 17.
Other Names:Drug: PA-824
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768273
|United States, Nebraska|
|MDS Pharma Services|
|Lincoln, Nebraska, United States, 68502|
|Principal Investigator:||Scott Rasmussen, M.D.||MDS Pharma Services|