Status:
COMPLETED
Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief 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. Sub...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 -
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04018274
Start Date
August 9 2019
End Date
October 16 2019
Last Update
November 15 2019
Active Locations (2)
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1
Quotient Sciences Screening Office
Coral Gables, Florida, United States, 33134
2
Quotient Sciences, Miami
Miami, Florida, United States, 33126