A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
NCT ID: NCT05985590
Last Updated: 2024-01-24
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
37 participants
INTERVENTIONAL
2023-08-18
2023-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment A: DRSP/EE
Drospirenone/Ethinyl Estradiol
Specified dose on specified days
Treatment B: BMS-986278/DRSP/EE
BMS-986278
Specified dose on specified days
Drospirenone/Ethinyl Estradiol
Specified dose on specified days
Interventions
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BMS-986278
Specified dose on specified days
Drospirenone/Ethinyl Estradiol
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body weight ≥ 45 kg.
* Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.
Exclusion Criteria
* Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening).
* Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator.
18 Years
65 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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Local Institution - 0002
Québec, Quebec, Canada
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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IM027-1013
Identifier Type: -
Identifier Source: org_study_id
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