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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fluvoxamine; Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03930602

IM011-088

Details and patient eligibility

About

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

BMS-986165+Fluvoxamine

Experimental group

Treatment:

Drug: Fluvoxamine

Drug: BMS-986165

BMS-986165 only

Experimental group

Treatment:

Drug: BMS-986165

Fluvoxamine only

Experimental group

Treatment:

Drug: Fluvoxamine