A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2021-12-16

Brief Summary

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This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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OC only

Subjects will receive a single dose of an oral contraceptive during the first period of the study

Group Type EXPERIMENTAL

Ethinyl estradiol (EE) and levonogestrel (LN)

Intervention Type DRUG

Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

PF-06650833 + OC

Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10.

Group Type EXPERIMENTAL

PF-06650833

Intervention Type DRUG

400 mg by mouth (PO) Once daily (QD) for 11 days

Ethinyl estradiol (EE) and levonogestrel (LN)

Intervention Type DRUG

Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Interventions

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PF-06650833

400 mg by mouth (PO) Once daily (QD) for 11 days

Intervention Type DRUG

Ethinyl estradiol (EE) and levonogestrel (LN)

Single dose of Oral tablet containing 30 ug EE and 150 ug of LN

Intervention Type DRUG

Other Intervention Names

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Oral contraceptive (OC)

Eligibility Criteria

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Inclusion Criteria

1. Healthy female subjects
2. 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 will be eligible with adequate contraceptive usage.
3. Body mass index (BMI) of 17.5 to 30.5 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 alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
3. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
4. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
5. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
6. Benign ethnic (cyclic) neutropenia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes