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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Females

Treatments: Drug: PF-06651600; Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03608241

B7981018

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Treatment sequence 1

Experimental group

Description:

Treatment sequence 1 will receive a single dose of an oral contraceptive during the first period of the study (period 1) and then continue to the second period (Period 2) of the study where they will receive PF-06651600 every day for 11 days and a single dose of an oral contraceptive towards the end of the period.

Treatment:

Drug: PF-06651600

Drug: Ethinyl estradiol (EE) and levonogestrel (LN)

Treatment Sequence 2

Experimental group

Description:

Treatment sequence 2 will receive PF-06651600 every day for 11 days during the first period of the study (period 1) and a single dose of an oral contraceptive towards the end of this period. After completion of Period 1, there will be a washout period of at least 10 days before starting the second period of the study (period 2). During period 2, a single dose of an oral contraceptive will be received.

Treatment:

Drug: PF-06651600

Drug: Ethinyl estradiol (EE) and levonogestrel (LN)