Recruiting
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants - IM027-1013
Actualizada:
28 septiembre, 2023
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ClinicalTrials.gov
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Recruiting
Inclusion Criteria: - Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m^2), inclusive. - 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 significant acute or chronic medical illness. - 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. Note: Other protocol-defined inclusion/exclusion criteria apply.
Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica