A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05546151
Collaborator
(none)
24
3
7.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
Anticipated Study Start Date :
Sep 23, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort J1

Drug: BMS-986322
Specified dose on specified days

Other: Placebo for BMS-986322
Specified dose on specified days

Experimental: Cohort J2

Drug: BMS-986322
Specified dose on specified days

Other: Placebo for BMS-986322
Specified dose on specified days

Experimental: Cohort J3

Drug: BMS-986322
Specified dose on specified days

Other: Placebo for BMS-986322
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Number of participants with serious adverse events (SAEs) [Up to 7 weeks]

  2. Number of participants with adverse events (AEs) leading to discontinuation [Up to 7 weeks]

  3. Number of deaths [Up to 7 weeks]

  4. Number of participants with AEs [Up to 7 weeks]

  5. Number of participants with electrocardiogram (ECG) abnormalities [Up to 7 weeks]

  6. Number of participants with vital sign abnormalities [Up to 7 weeks]

  7. Number of participants with physical examination abnormalities [Up to 7 weeks]

  8. Number of participants with clinical laboratory abnormalities [Up to 7 weeks]

Secondary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) [Day 1 and Day 14]

  2. Time of maximum observed plasma concentration (Tmax) [Day 1 and Day 14]

  3. Area under the concentration-time curve within a dosing interval (AUC[TAU]) [Day 1 and Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participant must be of Japanese descent (both biological parents are ethnically Japanese).

  • In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.

  • Women should be of non-childbearing potential.

Exclusion Criteria:
  • Any significant acute or chronic medical illness.

  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.

  • Any major surgery within 90 days of study drug administration.

Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Locations

No locations specified.

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:
NCT05546151
Other Study ID Numbers:
  • IM032-042
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb

Study Results

No Results Posted as of Sep 19, 2022