This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
29
50 mg by mouth (PO) once daily (QD)
Oral tablet containing 30 ug EE and 150 ug of LN
Quotient Sciences Screening Office
Coral Gables, Florida, United States
Quotient Sciences, Miami
Miami, Florida, United States
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
30 micrograms administered as oral OC combination tablet
Time frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
150 micrograms administered as oral OC combination tablet
Time frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
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