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Completed

NCT Number: NCT05805904

A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants

The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese participants.

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be Chinese (both biological parents are ethnically Chinese).
  • Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
  • Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height [m])2.
  • Body weight ≥ 50 kg

Exclusion criteria

  • Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome)
  • Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable)
  • Women who are of childbearing potential
  • Women who are breastfeeding
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate < 90 mL/min/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days.

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 19

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 19

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to Day 19

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 26

  2. Number of participants with physical examination abnormalities

    Time frame: Up to Day 19

  3. Number of participants with vital sign abnormalities

    Time frame: Up to Day 19

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 19

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 19

  6. Cmax

    Time frame: Up to Day 19

  7. Tmax

    Time frame: Up to Day 19

  8. AUC(0-T)

    Time frame: Up to Day 19

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Sep 18, 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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