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OpenTrials
Completed

NCT Number: NCT04444050

Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
  • A body mass index of 18 - 32 kg/m2, inclusive
  • Women and men must agree to follow specific methods of contraception, if applicable

For J-MAD Part 3

  • Must be Japanese (both biological parents are ethnically Japanese)

Exclusion criteria

  • Women who are of childbearing potential
  • Women who are pregnant or breastfeeding
  • 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 surgery within 12 weeks of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986331

Drug

Specified dose on specified days

Placebo, Matching BMS-986331

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 13 months

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 46 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 46 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 46 days

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 17 days

  2. Time to reach Cmax in plasma (Tmax)

    Time frame: Up to 17 days

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

    Time frame: Up to 17 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Oct 20, 2022

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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