A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

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 of approximately 15 healthy female participants will be enrolled and dosed to achieve at least 12 participants completing the study.

Key facts

Study ID

NCT04134715

Run by

Pfizer

People needed

15

Starts

2019-10-23

Expected to finish

2020-01-09

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

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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