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

Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996879

Enrollment

Registered

2009-10-16

Start date

2013-05-31

Completion date

2013-09-30

Last updated

2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Human Volunteers

Brief summary

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

Interventions

DRUGMidazolam

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

DRUGBMS-791325

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026