NCT04550195

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2020

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

September 11, 2020

Last Update Submit

February 9, 2022

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (16)

  • Incidence of Adverse Events (AEs)

    Up to 30 days

  • Incidence of Serious Adverse Events (SAEs)

    Up to 81 days

  • Incidence of AEs leading to discontinuation

    Up to 30 days

  • Number of clinically significant changes in clinical laboratory values: Hematology tests

    Up to 51 days

  • Number of clinically significant changes in clinical laboratory values: Urinalysis tests

    Up to 51 days

  • Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests

    Up to 51 days

  • Number of clinically significant changes from baseline in vital signs: Heart Rate

    Up to 51 days

  • Number of clinically significant changes from baseline in vital signs: Body Temperature

    Up to 51 days

  • Number of clinically significant changes from baseline in vital signs: Blood Pressure

    Up to 51 days

  • Number of clinically significant changes from baseline in vital signs: Respiratory Rate

    Up to 51 days

  • Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)

    Up to 51 days

  • Number of clinically significant changes from baseline in physical examinations

    Up to 51 days

  • Number of clinically significant changes in ECG parameters: PR interval

    PR interval is the time from the onset of the P wave to the start of the QRS complex

    Up to 51 days

  • Number of clinically significant changes in ECG parameters: QRS duration

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

    Up to 51 days

  • Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)

    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 51 days

  • Number of clinically significant changes in ECG parameters: QT interval

    The QT interval is the time from the start of the Q wave to the end of the T wave.

    Up to 51 days

Study Arms (13)

Part A Single Ascending Dose (SAD) Cohort A1

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part A SAD Cohort A2

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part A SAD Cohort A3

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part A SAD Cohort A4

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part A SAD Cohort A5

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part A SAD Cohort A6

EXPERIMENTAL
Drug: BMS-986337Biological: Famotidine

Part B Multiple Ascending Dose (MAD) Cohort B1

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part B MAD Cohort B2

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part B MAD Cohort B3

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part B MAD Cohort B4

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part C MAD in Japanese Healthy participants Cohort C1

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part C MAD in Japanese Healthy participants Cohort C2

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Part C MAD in Japanese Healthy participants Cohort C3

EXPERIMENTAL
Drug: BMS-986337Other: BMS-986337 Placebo

Interventions

BMS-986337DRUG

Specified Dose on Specified Days

Part A SAD Cohort A2Part A SAD Cohort A3Part A SAD Cohort A4Part A SAD Cohort A5Part A SAD Cohort A6Part A Single Ascending Dose (SAD) Cohort A1Part B MAD Cohort B2Part B MAD Cohort B3Part B MAD Cohort B4Part B Multiple Ascending Dose (MAD) Cohort B1Part C MAD in Japanese Healthy participants Cohort C1Part C MAD in Japanese Healthy participants Cohort C2Part C MAD in Japanese Healthy participants Cohort C3
BMS-986337 PlaceboOTHER

Specified Dose on Specified Days

Part A SAD Cohort A2Part A SAD Cohort A3Part A SAD Cohort A4Part A SAD Cohort A5Part A Single Ascending Dose (SAD) Cohort A1Part B MAD Cohort B2Part B MAD Cohort B3Part B MAD Cohort B4Part B Multiple Ascending Dose (MAD) Cohort B1Part C MAD in Japanese Healthy participants Cohort C1Part C MAD in Japanese Healthy participants Cohort C2Part C MAD in Japanese Healthy participants Cohort C3
FamotidineBIOLOGICAL

Specified Dose on Specified Days

Part A SAD Cohort A6

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
  • For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
  • Body mass index (BMI) of 18.0 kg/m\^2 to 30.0 kg/m\^2, inclusive, at screening; BMI = weight (kg)/height (m)\^2
  • Women and men must agree to follow specific methods of contraception, if applicable

You may not qualify if:

  • Women who are of childbearing potential
  • Women who are breastfeeding
  • Prior exposure to BMS-986278
  • Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Plc (PRA Health Sciences) - Netherlands

Groningen, 9728 NZ, Netherlands

Location

Related Links

MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 16, 2020

Study Start

September 17, 2020

Primary Completion

March 3, 2021

Study Completion

March 3, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

NL(1)