A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04550195
Collaborator
(none)
26
1
13
5.5
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Mar 3, 2021
Actual Study Completion Date :
Mar 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A Single Ascending Dose (SAD) Cohort A1

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part A SAD Cohort A2

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part A SAD Cohort A3

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part A SAD Cohort A4

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part A SAD Cohort A5

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part A SAD Cohort A6

Drug: BMS-986337
Specified Dose on Specified Days

Biological: Famotidine
Specified Dose on Specified Days

Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part B MAD Cohort B2

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part B MAD Cohort B3

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part B MAD Cohort B4

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part C MAD in Japanese Healthy participants Cohort C1

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part C MAD in Japanese Healthy participants Cohort C2

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Experimental: Part C MAD in Japanese Healthy participants Cohort C3

Drug: BMS-986337
Specified Dose on Specified Days

Other: BMS-986337 Placebo
Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 30 days]

  2. Incidence of Serious Adverse Events (SAEs) [Up to 81 days]

  3. Incidence of AEs leading to discontinuation [Up to 30 days]

  4. Number of clinically significant changes in clinical laboratory values: Hematology tests [Up to 51 days]

  5. Number of clinically significant changes in clinical laboratory values: Urinalysis tests [Up to 51 days]

  6. Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests [Up to 51 days]

  7. Number of clinically significant changes from baseline in vital signs: Heart Rate [Up to 51 days]

  8. Number of clinically significant changes from baseline in vital signs: Body Temperature [Up to 51 days]

  9. Number of clinically significant changes from baseline in vital signs: Blood Pressure [Up to 51 days]

  10. Number of clinically significant changes from baseline in vital signs: Respiratory Rate [Up to 51 days]

  11. Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR) [Up to 51 days]

  12. Number of clinically significant changes from baseline in physical examinations [Up to 51 days]

  13. Number of clinically significant changes in ECG parameters: PR interval [Up to 51 days]

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

  14. Number of clinically significant changes in ECG parameters: QRS duration [Up to 51 days]

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

  15. Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's) [Up to 51 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.

  16. Number of clinically significant changes in ECG parameters: QT interval [Up to 51 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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/m2 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)^2

  • Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:
  • 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

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 ICON Plc (PRA Health Sciences) - Netherlands Groningen Netherlands 9728 NZ

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:
NCT04550195
Other Study ID Numbers:
  • IM037-009
  • 2019-004518-32
First Posted:
Sep 16, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Bristol-Myers Squibb
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022