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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: BMS-791325; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996879

AI443-006

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

48 participants in 1 patient group

Midazolam + BMS-791325

Experimental group

Treatment:

Drug: BMS-791325

Drug: Midazolam