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

A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: BMS-986172

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • ICON Plc (Legacy PRA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: SAD; SAD = Single Ascending Dose	Other: Placebo; Specified dose on specified days; Drug: BMS-986172; Specified dose on specified days
Experimental: Part B: MAD; MAD = Multiple Ascending Dose	Other: Placebo; Specified dose on specified days; Drug: BMS-986172; Specified dose on specified days
Experimental: Part C: JMAD; JMAD= Japanese Multiple Ascending Dose	Other: Placebo; Specified dose on specified days; Drug: BMS-986172; Specified dose on specified days
Experimental: Part D: FE/BA; FE/BA = Food Effect/Relative Bioavailability	Drug: BMS-986172; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of non-serious Adverse Events (AEs)		Up to 35 days
Incidence of Serious Adverse Events (SAEs)		Up to 35 days
Incidence of AEs leading to discontinuation of study treatment		Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 28 days
Incidence of clinically significant changes in physical examination		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 clinical laboratory values: Urinalysis tests		Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests		Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF	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	Up to 28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Healthy Participants; BMS-986172
• Other Study ID Numbers: MB008-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No