Status:
COMPLETED
A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, fixed sequence, multiple dose, open label study of the effect of PF-06826647 on oral contraceptive (OC) pharmacokinetics (PK) and vice versa in healthy female participants. A total ...
Eligibility Criteria
Inclusion
- 1\. Healthy female participants of non-childbearing potential must be 18 to 60 years of age, inclusive
- 2\. Female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, laboratory tests, and 12 lead ECG
- 3\. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- 4\. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
Exclusion
- 1\. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- 2\. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- 3\. History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives).
- 4\. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- 5\. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
- 6\. Participants who use tobacco or nicotine containing products.
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04134715
Start Date
October 23 2019
End Date
January 9 2020
Last Update
February 5 2020
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