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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT05805904

IM027-067

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Drug: BMS-986278

Drug: Placebo

Group 2

Experimental group

Treatment:

Drug: BMS-986278

Drug: Placebo