A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OC only Subjects will receive a single dose of an oral contraceptive during the first period of the study |
Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Other Names:
|
| Experimental: PF-06650833 + OC Subjects will receive PF-06650833 every day for 11 days and a single dose of an oral contraceptive on day 10. |
Drug: PF-06650833
400 mg by mouth (PO) Once daily (QD) for 11 days
Drug: Ethinyl estradiol (EE) and levonogestrel (LN)
Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area Under the Curve From Time zero to the time of the last quantifiable concentration (AUClast) for EE [0(pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post dose]
AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time of the last quantifiable concentration
- Area Under the Curve From Time zero to the time of the last quantifiable concentration (AUClast) for LN [0(pre-dose), 1, 1.5, 2, 4, 6, 8, 12, 24, 36 and 48 hours post dose]
AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time of the last quantifiable concentration
- Maximum Plasma Concentration (Cmax) for EE [Day 1 in Period 1 and Day 10 in Period 2]
Cmax will be observed directly from data.
- Maximum Plasma Concentration (Cmax) for LN [Day 1 in Period 1 and Day 10 in Period 2]
Cmax will be observed directly from data.
Secondary Outcome Measures
- 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 (Day 0) up to 28 days after last dose of study drug]
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
-
Healthy female subjects
-
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 will be eligible with adequate contraceptive usage.
- 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:
-
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 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).
-
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
-
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
-
Benign ethnic (cyclic) neutropenia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qps-Mra, Llc | South Miami | Florida | United States | 33143 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7921026