A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

Completed · Phase 1

Conditions studied: Healthy Females

In brief

This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.

Key facts

Study ID

NCT03608241

Run by

Pfizer

People needed

12

Starts

2018-09-21

Expected to finish

2018-11-23

Last updated by the study team

2019-04-09

Who can join

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

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
• Healthy female subjects of non childbearing potential
• 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; and have 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 and are not eligible for this study.
• Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

You may not qualify if…

• Subjects with any of the following characteristics/conditions will not be included in the study:
• 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).
• History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
• 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.
• Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
• Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
• Subjects who have a malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing

Where it is running

• Quotient Sciences — Coral Gables, Florida, United States
• Quotient Sciences-Miami, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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