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

Last updated on April 11, 2019

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Study Location
Quotient Sciences
Coral Gables, Florida, 33134 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Females
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:

1. Healthy female subjects of non childbearing potential

Female subjects of non childbearing potential must meet at least 1 of the following
criteria:

1. 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;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. 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.

2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects with any of the following characteristics/conditions will not be included in the
study:

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. History of drug abuse with less than 6 months of abstinence prior to the baseline
visit.

3. 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.

4. 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.

5. Subjects with a known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.

6. 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.

7. Any current evidence of untreated active or latent or inadequately treated infection
with Mycobacterium tuberculosis (TB).

8. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing

NCT03608241
Pfizer
Completed
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

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Pfizer Clinical Trials Contact Center

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[email protected]

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