Clinical trial NCT05805904: A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 19
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 19
measure: Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 19
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 26
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 19
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 19
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 19
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 19
measure: Cmax
timeFrame: Up to Day 19
measure: Tmax
timeFrame: Up to Day 19
measure: AUC(0-T)
timeFrame: Up to Day 19
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: