A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: BMS-986337 Placebo; Drug: BMS-986337; Biological: Famotidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04550195

IM037-009

2019-004518-32 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.

Enrollment: 26 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
• For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
• Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2
• Women and men must agree to follow specific methods of contraception, if applicable

Exclusion criteria

• Women who are of childbearing potential
• Women who are breastfeeding
• Prior exposure to BMS-986278
• Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 13 patient groups

Part A Single Ascending Dose (SAD) Cohort A1

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part A SAD Cohort A2

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part A SAD Cohort A3

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part A SAD Cohort A4

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part A SAD Cohort A5

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part A SAD Cohort A6

Experimental group

Treatment:

Drug: BMS-986337

Biological: Famotidine

Part B Multiple Ascending Dose (MAD) Cohort B1

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part B MAD Cohort B2

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part B MAD Cohort B3

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part B MAD Cohort B4

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part C MAD in Japanese Healthy participants Cohort C1

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part C MAD in Japanese Healthy participants Cohort C2

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337

Part C MAD in Japanese Healthy participants Cohort C3

Experimental group

Treatment:

Other: BMS-986337 Placebo

Drug: BMS-986337