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

Phase 1CompletedNCT00996879

Bristol-Myers Squibb48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

MidazolamDRUG

Syrup, Oral, 5 mg, Single dose, 2 days

BMS-791325DRUG

Capsules, Oral, 300 mg, Every 12 hours, 8 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Wcct Global, Llc

Cypress, California, United States

Outcomes

Primary Outcomes

Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)

Time frame: Within 24 hours of dosing

Secondary Outcomes

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

Time frame: On Days 1, 2, 4, 6, 8, 9, and 10

Data from ClinicalTrials.gov

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