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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137708
• Other study ID #: A3921071
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2010
• Last updated: August 5, 2010
• Start date: June 2010
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)		12 days	No
Secondary	AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)		12 days	No
Secondary	Number of adverse events and number of participants with adverse events		12 days	Yes
Secondary	Changes in complete blood count and serum chemistry profile		12 days	Yes
Secondary	Changes in vital signs		12 days	Yes

External Links

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