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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01137708
Collaborator
(none)
20
1
2
30
20.3

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
  • 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)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Sequence 1

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

  1. AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) [12 days]

Secondary Outcome Measures

  1. AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN) [12 days]

  2. Number of adverse events and number of participants with adverse events [12 days]

  3. Changes in complete blood count and serum chemistry profile [12 days]

  4. Changes in vital signs [12 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01137708
Other Study ID Numbers:
  • A3921071
First Posted:
Jun 4, 2010
Last Update Posted:
Aug 6, 2010
Last Verified:
Aug 1, 2010

Study Results

No Results Posted as of Aug 6, 2010