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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT04926051

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986172 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jun 15, 2021

Actual Primary Completion Date :

Dec 28, 2021

Actual Study Completion Date :

Dec 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON Plc (Legacy PRA)	Lenexa	Kansas	United States	66215

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT04926051

Other Study ID Numbers:

MB008-009

First Posted:

Jun 14, 2021

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bristol-Myers Squibb

Healthy Participants

BMS-986172

Study Results

No Results Posted as of Jun 6, 2022