Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Midazolam; Drug: BMS-791325

• Registration Number: NCT00996879
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2013-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
• Women who are not of childbearing potential

Exclusion Criteria

• Women of childbearing potential
• Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
• Gastrointestinal disease that may impact the absorption of study drug
• History of any chronic respiratory disease (asthma, COPD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midazolam + BMS-791325	BMS-791325	-
Midazolam + BMS-791325	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)	Within 24 hours of dosing

Secondary Outcome Measures

Name	Time	Method
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests	On Days 1, 2, 4, 6, 8, 9, and 10

Trial Locations

Locations (1)

Wcct Global, Llc; 🇺🇸 Cypress, California, United States