NCT03662516

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

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-04965842 ON THE PHARMACOKINETICS OF SINGLE-DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

In Treatment Sequence 1, Period 1 Day 1, subjects will be dosed with a single administration of OC in the form of 1 PORTIA (ethyinyl estradiol \[EE\] and levonorgestrel \[LN\]) or equivalent tablet, orally. OC (EE and LN) PK will then be assessed at pre dose and over 48 hours after OC dosing. Period 1 will be immediately followed by Period 2 with no washout. The 48 hours post-OC dose PK sample for Period 1 must be collected prior to receiving the first dose of PF 04965842 in Period 2. In Period 2, subjects will be dosed with 200 mg PF 04965842 PO QD for 9 days followed by administration of a single dose of OC oral tablet immediately after administration of a 200 mg dose of PF-04965842 on the morning of Day 10. OC PK in Period 2 will be assessed at pre dose and over 48 hours after OC dosing. Dosing with 200 mg PF 04965842 PO QD will continue until Day 11. In Treatment Sequence 2, Period 1, subjects will be dosed with 200 mg PF 04965842 PO QD for 9 days followed by administration of a single dose of OC oral tablet immediately after administration of a 200 mg dose of PF-04965842 on the morning of Day 10. OC PK will be assessed at pre dose and over 48 hours following OC dosing. Dosing with 200 mg PF 04965842 PO QD will continue until Day 11. Subjects will then undergo a washout period of at least 10 days (Day -1 of Period 2 starts 10 days after Day 12 of Period 1). In Period 2 subjects will be dosed with a single OC administration on Day 1. OC PK will then be assessed at pre dose and over 48 hours after OC dose.

Conditions

• Healthy Females

Interventions

Type	Name	Description
DRUG	PF-04965842	Orally bioavailable small molecule that selectively inhibits JAK 1 by blocking the adenosine triphosphate (ATP) binding site.
DRUG	Ethinyl estradiol (EE) and levonorgestrel (LN)	Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Timeline

• Start date: 2018-09-26
• Primary completion: 2019-01-19
• Completion: 2019-01-19
• First posted: 2018-09-07
• Last updated: 2020-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study