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

NCT05805904 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-067
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Up to Day 19

• Time of maximum observed concentration (Tmax)

  Up to Day 19

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

  Up to Day 19

Secondary Outcomes (8)

• Number of participants with Adverse Events (AEs)

  Up to Day 26

• Number of participants with physical examination abnormalities

  Up to Day 19

• Number of participants with vital sign abnormalities

  Up to Day 19

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 19

• Number of participants with clinical laboratory abnormalities

  Up to Day 19

Study Arms (2)

Group 1

EXPERIMENTAL

Drug: BMS-986278; Drug: Placebo

Group 2

EXPERIMENTAL

Drug: BMS-986278; Drug: Placebo

Interventions

BMS-986278 DRUG

Specified dose on specified days.

Group 1; Group 2

Placebo DRUG

Specified dose on specified days

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Shanghai, 200032, China

Location

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: March 29, 2023
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CN (1)