ClinicalTrials.gg
Sign In
CompletedNCT04926051Updated Jun 6, 2022

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 interventional study of BMS-986172 and Placebo in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2021, 4 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy Participants
  • BMS-986172
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Part A: SAD

    SAD = Single Ascending Dose

    Drug: BMS-986172 · Other: Placebo

  • Experimental
    Part B: MAD

    MAD = Multiple Ascending Dose

    Drug: BMS-986172 · Other: Placebo

  • Experimental
    Part C: JMAD

    JMAD= Japanese Multiple Ascending Dose

    Drug: BMS-986172 · Other: Placebo

  • Experimental
    Part D: FE/BA

    FE/BA = Food Effect/Relative Bioavailability

    Drug: BMS-986172

Interventions

  • DrugBMS-986172

    Specified dose on specified days

  • OtherPlacebo

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Incidence of non-serious Adverse Events (AEs)

    Time frame: Up to 35 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 35 days

  3. Incidence of AEs leading to discontinuation of study treatment

    Time frame: Up to 35 days

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 28 days

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 28 days

  6. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 28 days

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 28 days

  8. Incidence of clinically significant changes in physical examination

    Time frame: Up to 28 days

  9. Incidence of clinically significant changes in clinical laboratory values: Hematology tests

    Time frame: Up to 28 days

  10. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests

    Time frame: Up to 28 days

  11. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

    Time frame: Up to 28 days

  12. Incidence of clinically significant changes in clinical laboratory values: Serology tests

    Time frame: Up to 28 days

  13. 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

    Time frame: Up to 28 days

Secondary outcomes

  1. Plasma concentrations of BMS-986172

    Time frame: Up to 28 days

  2. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 28 days

  3. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

    Time frame: Up to 28 days

07

Study locations

1 site
  • ICON Plc (Legacy PRA)
    Lenexa, Kansas 66215, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04926051
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Jun 15, 2021
Primary completion
Dec 28, 2021
Completion
Dec 28, 2021
Last update
Jun 6, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Bristol-Myers Squibb →

Start the discussion