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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT04926051

Run by

Bristol-Myers Squibb

People needed

40

Starts

2021-06-15

Expected to finish

2021-12-28

Last updated by the study team

2022-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ICON Plc (Legacy PRA) — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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