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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00902460
First received: May 14, 2009
Last updated: August 12, 2009
Last verified: August 2009

May 14, 2009
August 12, 2009
June 2009
July 2009   (final data collection date for primary outcome measure)
AUCinf of midazolam [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
To demonstrate the lack of effect of multiple dose CP-690,550 on the pharmacokinetics of a single, oral dose of midazolam in healthy volunteers [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902460 on ClinicalTrials.gov Archive Site
  • AUClast, Cmax, Tmax, t1/2 of midazolam [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
  • Vital signs, laboratory tests and adverse events [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of a single oral dose of midazolam when co administered with CP-690,550 [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00902460
A3921059
No
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