Skip to main content
OpenTrials
Completed

NCT Number: NCT05350800

A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Miami, Florida, 33136, 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 (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants
  • Must have a normal or clinically-acceptable 12-lead ECG at screening
  • Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1

Exclusion criteria

  • Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
  • History of major surgery within 8 weeks before the first dose administration

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986369

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Day 1

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Day 1

  3. Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to 336 hours after dose administration

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: From the date of having consented until 30 days after completion of study treatment

  2. Number of participants with vital sign abnormalities

    Time frame: Up to Day 15

  3. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 15

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 15

  5. Effect of BMS-986369 on ECG parameters - Part 1

    Time frame: Up to 72 hours

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food the Bioavailability of BMS-986369 in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2022
Registry last updated
Jul 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.