Trials / Completed
CompletedNCT03608241
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE SUBJECTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06651600 | 200 mg by mouth (PO) Once daily (QD) for 11 days |
| DRUG | Ethinyl estradiol (EE) and levonogestrel (LN) | Single dose of Oral tablet containing 30 ug EE and 150 ug of LN |
Timeline
- Start date
- 2018-09-21
- Primary completion
- 2018-11-23
- Completion
- 2018-11-23
- First posted
- 2018-07-31
- Last updated
- 2019-04-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03608241. Inclusion in this directory is not an endorsement.