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OpenTrials
Completed

NCT Number: NCT05760937

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

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

  • Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive.
  • Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
  • A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.

Exclusion criteria

  • Participant has any condition that confounds the ability to interpret data from the study.
  • Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
  • Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986447

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 59 days

  2. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to 59 days

  3. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to 34 days

  4. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to 35 days

  5. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to 35 days

  6. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to 34 days

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 72 hours postdose

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 72 hours postdose

  3. Apparent terminal phase half-life (T-Half)

    Time frame: Up to 72 hours postdose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2023
Registry last updated
Apr 5, 2024

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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