NCT00996879CompletedPhase 1
Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects
Bristol-Myers Squibb1 site in 1 country48 target enrollmentStarted: May 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)
Study Overview
Brief Summary
The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Midazolam + BMS-791325
Experimental
Intervention: BMS-791325 (Drug)
Midazolam + BMS-791325
Experimental
Intervention: Midazolam (Drug)
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(On Days 1, 2, 4, 6, 8, 9, and 10)
Investigators
Study Sites (1)
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