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Recruiting

Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165 - IM011-088

Updated: 14 May, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-50

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986165 only
Drug: BMS-986165
Experimental: BMS-986165+Fluvoxamine
Drug: Fluvoxamine Drug: BMS-986165
Experimental: Fluvoxamine only
Drug: Fluvoxamine

Key Eligibility Criteria

Inclusion Criteria: - Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator. - Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening. - Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. Exclusion Criteria: - Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, - Any major surgery within 4 weeks of study drug administration - Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Have questions? Live support is available 24/7 - Call 855-907-3286 or Email Us

Have questions? Live support is available 24/7 -
Call 855-907-3286 or Email Us