A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

Phase 1 Completed 17 enrolled Pfizer

RandomizedCrossoverOpen-labelOther

Summary

This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 04965842 on single-dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 16 healthy female subjects (8 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.

Timeline

Start: 2018-09-26
Primary completion: 2019-01-19
Completion: 2019-01-19

Publications

Wang X, Dowty ME, Tripathy S, Le VH, Huh Y, Curto M, Winton JA, O'Gorman MT, Chan G, Malhotra BK. Assessment of the Effects of Abrocitinib on the Pharmacokinetics of Probe Substrates of Cytochrome P450 1A2, 2B6 and 2C19 Enzymes and Hormonal Oral Contraceptives in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2024 May;49(3):367-381. doi: 10.1007/s13318-024-00893-5. Epub 2024 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abrocitinib	Small molecule	200 mg	Oral
Subject	Levonorgestrel	Small molecule	150 ug	Oral
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

Indications

No indication recorded.