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

NCT04018274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-11-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

PF-06651600

50 mg by mouth (PO) once daily (QD)

DRUG

Ethinyl estradiol (EE) and levonorgestrel(LN)

Oral tablet containing 30 ug EE and 150 ug of LN

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2019-10-16
Completion
2019-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018274 on ClinicalTrials.gov