Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT03662516
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: