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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Midazolam + BMS-791325

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

BMS-791325

Intervention Type DRUG

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

Interventions

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Midazolam

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

Intervention Type DRUG

BMS-791325

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes