CP-690,550 And Oral Contraception Drug-Drug Interaction Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment Sequence 1
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Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)
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
|
Experimental: Treatment Sequence 2
|
Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)
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
|
Outcome Measures
Primary Outcome Measures
- AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) [12 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy female subjects
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No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
Exclusion Criteria:
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Any medical reason which would contraindicate the administration of oral contraceptives
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Clinically significant infections within the past 3 months or history of febrile illness within 5 days
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Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
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Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Bruxelles | Belgium | B-1070 |
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.- A3921071