CP-690,550 And Oral Contraception Drug-Drug Interaction Study

Study Overview
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Brief Summary
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This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.

Official Title
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A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)
* Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis Exclusion Criteria: Any medical reason which would contraindicate the administration of oral contraceptives Clinically significant infections within the past 3 months or history of febrile illness within 5 days Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br> | Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)<br>* Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID<br>|
| Experimental: Treatment Sequence 2<br> | Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)<br>* Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN) |  | 12 days | 
| Number of adverse events and number of participants with adverse events |  | 12 days | 
| Changes in complete blood count and serum chemistry profile |  | 12 days | 
| Changes in vital signs |  | 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug interactions, CYP3A, oral contraceptive, anti-rheumatic agents