This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
200 mg by mouth (PO) Once daily (QD) for 11 days
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Quotient Sciences
Coral Gables, Florida, United States
Quotient Sciences-Miami, Inc.
Miami, Florida, United States
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 28 days after last dose of study drug
Number of Adverse Events by Severity
Time frame: Baseline up to 28 days after last dose
Number of Participants With Categorical Vital Signs Data
Time frame: Baseline through study completion, approximately 23 days.
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline through study completion, approximately 23 days.
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