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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986172; Other: Placebo

• Registration Number: NCT04926051
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-14
• Study Start: 2021-06-15
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B: MAD	Placebo	MAD = Multiple Ascending Dose
Part C: JMAD	BMS-986172	JMAD= Japanese Multiple Ascending Dose
Part C: JMAD	Placebo	JMAD= Japanese Multiple Ascending Dose
Part A: SAD	BMS-986172	SAD = Single Ascending Dose
Part D: FE/BA	BMS-986172	FE/BA = Food Effect/Relative Bioavailability
Part A: SAD	Placebo	SAD = Single Ascending Dose
Part B: MAD	BMS-986172	MAD = Multiple Ascending Dose

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAEs)	Up to 35 days
Incidence of clinically significant changes in physical examination	Up to 28 days
Incidence of AEs leading to discontinuation of study treatment	Up to 35 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests	Up to 28 days
Incidence of non-serious Adverse Events (AEs)	Up to 35 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests	Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests	Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests	Up to 28 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF	Up to 28 days	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))	Up to 28 days
Plasma concentrations of BMS-986172	Up to 28 days
Maximum observed plasma concentration (Cmax)	Up to 28 days

Trial Locations

Locations (1)

ICON Plc (Legacy PRA); 🇺🇸 Lenexa, Kansas, United States