A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

Completed · Phase 1

Conditions studied: Healthy Females

In brief

This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 04965842 on single-dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 16 healthy female subjects (8 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.

Key facts

Study ID

NCT03662516

Run by

Pfizer

People needed

17

Starts

2018-09-26

Expected to finish

2019-01-19

Last updated by the study team

2020-03-23

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy female subjects of both childbearing and non-childbearing potential who, at the time of Screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
• Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Evidence of acute exacerbation of dermatological condition (eg, AD or psoriasis) or visible rash present during physical examination.
• Subjects, who according to the product label for OC, would be at increased risk if dosed with OC.
• Based on PORTIA product label, combination OCs should not be used in women with any of the following conditions:
• Thrombophlebitis or thromboembolic disorders.
• A past history of deep-vein thrombophlebitis or thromboembolic disorders.
• Cerebral-vascular or coronary artery disease.
• Thrombogenic valvulopathies.
• Thrombogenic rhythm disorders.
• Diabetes mellitus with vascular involvement.
• Uncontrolled hypertension.
• Known or suspected carcinoma of the breast.
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
• Undiagnosed abnormal genital bleeding.
• Cholestatic jaundice of pregnancy or jaundice with prior pill use.
• Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal.
• Known or suspected pregnancy.
• Hypersensitivity to any of the components of Portia (LN and EE tablets).
• Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug test.
• History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before Screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
• Screening supine systolic BP <90 mm Hg or 140 mm Hg following at least 5 minutes of supine rest or Screening supine diastolic BP <50 mm Hg or 90 mm Hg following at least 5 minutes of supine rest.
• If a subject meets any of these criteria, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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