A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
NCT ID: NCT05891262
Last Updated: 2023-09-25
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
15 participants
INTERVENTIONAL
2023-06-06
2023-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-986196 and Loestrin
BMS-986196
Specified dose on specified days
Loestrin
Specified dose on specified days
Interventions
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BMS-986196
Specified dose on specified days
Loestrin
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m\^2), inclusive, at screening.
* Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Exclusion Criteria
* History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator).
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure).
* Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention.
18 Years
45 Years
FEMALE
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
Cypress, California, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM038-023
Identifier Type: -
Identifier Source: org_study_id
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