Healthy Females
Conditions
Keywords
female, post-menopausal, healthy, oral contraceptive
Brief summary
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.
Interventions
DRUGPF-06651600
200 mg by mouth (PO) Once daily (QD) for 11 days
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for EE | 0 (pre-dose),1, 1.5. 2,4,6,8,12,24 and 48 hours post-dose | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for LN | 0 (pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline (Day 0) up to 28 days after last dose of study drug |
| Number of Adverse Events by Severity | Baseline up to 28 days after last dose |
| Number of Participants With Categorical Vital Signs Data | Baseline through study completion, approximately 23 days. |
| Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline through study completion, approximately 23 days. |
Countries
United States
Outcome results
None listed