A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)
NCT ID: NCT05684289
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2023-01-03
2023-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: BMS-986278 + Sildenafil
BMS-986278
Specified dose on specified days
Sildenafil
Specified dose on specified days
Part 1: Placebo + Sildenafil
Sildenafil
Specified dose on specified days
Placebo
Specified dose on specified days
Part 2: BMS-986278
BMS-986278
Specified dose on specified days
Part 2: Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986278
Specified dose on specified days
Sildenafil
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)\^2 through 32.0 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2.
* Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Exclusion Criteria
* Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
* Any major surgery within 4 weeks of first study intervention administration.
35 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Altasciences Clinical Los Angeles, Inc
Cypress, California, United States
Syneos Health Clinical Research Services, Llc
Miami, Florida, United States
Countries
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Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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IM027-1017
Identifier Type: -
Identifier Source: org_study_id
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