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Completed

NCT Number: NCT05546151

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials Llc

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986322

Drug

Specified dose on specified days

Placebo for BMS-986322

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 7 weeks

  2. Number of participants with adverse events (AEs) leading to discontinuation

    Time frame: Up to 7 weeks

  3. Number of deaths

    Time frame: Up to 7 weeks

  4. Number of participants with AEs

    Time frame: Up to 7 weeks

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 7 weeks

  6. Number of participants with vital sign abnormalities

    Time frame: Up to 7 weeks

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 7 weeks

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 7 weeks

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Day 1 and Day 14

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Day 1 and Day 14

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

    Time frame: Day 1 and Day 14

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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