The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Anaheim, California, United States
Local Institution - 0002
Anaheim, California, United States
Maximum observed plasma concentration (Cmax) for EE/NET
Time frame: Up to 28 days
Cmax for EE/NET with BMS-986322
Time frame: Up to 28 days
Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
Time frame: Up to 28 days
AUC (tau) for EE/NET with BMS-986322
Time frame: Up to 28 days
Cmax for BMS-986322
Time frame: Up to 31 days
Cmax for BMS-986322 with EE/NET
Time frame: Up to 31 days
AUC (tau) for BMS-986322
Time frame: Up to 31 days
AUC (tau) for BMS-986322 with EE/NET
Time frame: Up to 31 days
Number of participants with Adverse Events (AEs)
Time frame: Up to 119 days
Number of participants with Serious AEs (SAEs)
Time frame: Up to 119 days
Number of participants with physical examination abnormalities
Time frame: Up to 119 days
Number of participants with vital sign abnormalities
Time frame: Up to 119 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 119 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 119 days
Time of maximum observed plasma concentration (Tmax) for EE/NET
Time frame: Up to 28 days
Tmax for EE/NET with BMS-986322
Time frame: Up to 28 days
Tmax for BMS-986322
Time frame: Up to 31 days
Tmax for BMS-986322 with EE/NET
Time frame: Up to 31 days