This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Miami Research Associates
Miami, Florida, United States
Covance Evansville Clinical Research Unit
Evansville, Indiana, United States
Maximum observed plasma concentration (Cmax) of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
Time frame: Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
Time frame: Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
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