The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Specified dose on specified days
Specified dose on specified days
Local Institution - 0002
Québec, Quebec, Canada
Maximum observed plasma concentration (Cmax)
Time frame: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Time frame: Predose and post-dose up to Day 28
Time of maximum observed concentration (Tmax)
Time frame: Predose and post-dose up to Day 28
Terminal half-life (T-Half)
Time frame: Predose and post-dose up to Day 28
Apparent total body clearance after extravascular administration (CL/F)
Time frame: Predose and post-dose up to Day 28
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 53
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 53
Number of Participants with AEs leading to discontinuation
Time frame: Up to Day 53
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 28
Number of Participants with Vital Sign Abnormalities
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Time frame: Up to Day 28
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 28
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to Day 27