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CP-690,550 and Midazolam Drug-Drug Interaction Study

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NCT00902460

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female (non-child bearing potential) subjects

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically significant infections within the past 3 months

- History of previously untreated infection with Mycobacterium tuberculosis

- Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or
human immunodeficiency virus

NCT00902460
Pfizer
Completed
CP-690,550 and Midazolam Drug-Drug Interaction Study

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CP-690,550 and Midazolam Drug-Drug Interaction Study
A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers
CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: midazolam; CP-690,550 + midazolam
    Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID
  • Drug: CP-690,550 + midazolam; midazolam
    Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone
  • Experimental: Treatment Sequence 1
    Intervention: Drug: midazolam; CP-690,550 + midazolam
  • Experimental: Treatment Sequence 2
    Intervention: Drug: CP-690,550 + midazolam; midazolam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female (non-child bearing potential) subjects

Exclusion Criteria:

  • Clinically significant infections within the past 3 months
  • History of previously untreated infection with Mycobacterium tuberculosis
  • Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00902460
A3921059
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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