Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT04018274
- Run by
- Pfizer
- People needed
- 29
- Starts
- 2019-08-09
- Expected to finish
- 2019-10-16
- Last updated by the study team
- 2019-11-15
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age and Sex:
- Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
- Female participants who are healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
You may not qualify if…
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
- Infection with hepatitis B or hepatitis C viruses -
Where it is running
- Quotient Sciences Screening Office — Coral Gables, Florida, United States
- Quotient Sciences, Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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