drugset / Trial / NCT04018274

Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids

NCT04018274

Phase 1 Completed 29 enrolled Pfizer
RandomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start
2019-08-09
Primary completion
2019-10-16
Completion
2019-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule 150 ug Oral
Subject Ritlecitinib Small molecule 50 mg Oral
Subject ethinyl estradiol Small molecule 30 ug Oral

Indications

No indication recorded.