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

NCT04926051 | Completed Phase 1 FDA Drug

• 1 other identifier: MB008-009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Healthy Participants; BMS-986172

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (3)

• 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

Study Arms (4)

Part A: SAD

EXPERIMENTAL

SAD = Single Ascending Dose

Drug: BMS-986172; Other: Placebo

Part B: MAD

EXPERIMENTAL

MAD = Multiple Ascending Dose

Drug: BMS-986172; Other: Placebo

Part C: JMAD

EXPERIMENTAL

JMAD= Japanese Multiple Ascending Dose

Drug: BMS-986172; Other: Placebo

Part D: FE/BA

EXPERIMENTAL

FE/BA = Food Effect/Relative Bioavailability

Drug: BMS-986172

Interventions

BMS-986172 DRUG

Specified dose on specified days

Part A: SAD; Part B: MAD; Part C: JMAD; Part D: FE/BA

Placebo OTHER

Specified dose on specified days

Part A: SAD; Part B: MAD; Part C: JMAD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

ICON Plc (Legacy PRA)

Lenexa, Kansas, 66215, United States

Location

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 14, 2021
• Study Start: June 15, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

US (1)