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

Pfizer15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-06826647DRUG

100 mg tablet

Oral Contraceptive (OC)DRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Quotient Sciences Screening Office

Coral Gables, Florida, United States

Quotient Sciences-Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Ethinyl Estradiol (EE)

Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

Time frame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)

Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUGtau) of Levonorgestrel (LN)

Area under the plasma concentration time profile from time 0 to end of dosing interval (AUCtau), where dosing interval is 24 hours.

Time frame: Day 14 in Period 2 (Period 2 is 14 days) and Day 16 in Period 3 (Period 3 is 17 days)

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06826647

AUCinf is calculated by AUClast + (Clast\*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)

Maximum Plasma Concentration (Cmax) of PF-06826647

Cmax will be observed directly from data.

Time frame: Day 1 in Period 1 (Period 1 is 2 days) and Period 3 (Period 3 is 17 days)

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.

Data from ClinicalTrials.gov

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