A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986172; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04926051

MB008-009

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
• Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years.
• BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.

Exclusion criteria

• Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
• History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
• Any significant acute or chronic medical illness.
• History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
• Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups

Part A: SAD

Experimental group

Description:

SAD = Single Ascending Dose

Treatment:

Other: Placebo

Drug: BMS-986172

Part B: MAD

Experimental group

Description:

MAD = Multiple Ascending Dose

Treatment:

Other: Placebo

Drug: BMS-986172

Part C: JMAD

Experimental group

Description:

JMAD= Japanese Multiple Ascending Dose

Treatment:

Other: Placebo

Drug: BMS-986172

Part D: FE/BA

Experimental group

Description:

FE/BA = Food Effect/Relative Bioavailability

Treatment:

Drug: BMS-986172