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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805904
• Other study ID #: IM027-067
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2023
• Est. completion date: May 23, 2023

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986278
Specified dose on specified days.
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution - 0001	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Up to Day 19
Primary	Time of maximum observed concentration (Tmax)		Up to Day 19
Primary	Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))		Up to Day 19
Secondary	Number of participants with Adverse Events (AEs)		Up to Day 26
Secondary	Number of participants with physical examination abnormalities		Up to Day 19
Secondary	Number of participants with vital sign abnormalities		Up to Day 19
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 19
Secondary	Number of participants with clinical laboratory abnormalities		Up to Day 19
Secondary	Cmax		Up to Day 19
Secondary	Tmax		Up to Day 19
Secondary	AUC(0-T)		Up to Day 19

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls