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

NCT ID: NCT04134715

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2020-01-09

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

Conditions

Healthy

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PF-06826647 alone then OC alone then OC+PF-06826647

In Period 1 (Period 1 is 2 days), participants will receive a single dose of PF-06826647 600 mg on Day 1. Period 2 (Period 2 is 14 days) will immediately follow Period 1 without any washout. In Period 2, the participants will receive OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet, orally starting from Period 2 Day 1 until Period 3-Day 16 (Period 3 is 17 Days). Period 3 will immediately follow Period 2 with no washout. In Period 3 on Day 1, the participants will receive a single dose of PF-06826647 600 mg. On Day 2 in Period 3, PF-06826647 will not be dosed. From Day 3, the participants will receive PF-06826647 600 mg QD for 14 days followed by OC in the form of 1 PORTIA (EE and LN) or equivalent tablet.

Group Type: EXPERIMENTAL

PF-06826647

Intervention Type: DRUG

100 mg tablet

Oral Contraceptive (OC)

Intervention Type: DRUG

OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet

Interventions

PF-06826647

100 mg tablet

Intervention Type: DRUG

Oral Contraceptive (OC)

OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Quotient Sciences Screening Office

Coral Gables, Florida, United States

Quotient Sciences-Miami

Miami, Florida, United States

Countries

United States

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C2501005

To obtain contact information for a study center near you, click here.

Other Identifiers

C2501005

Identifier Type: -

Identifier Source: org_study_id