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
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedAugust 13, 2009
August 1, 2009
1 month
May 14, 2009
August 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUCinf of midazolam
10 Days
Secondary Outcomes (2)
AUClast, Cmax, Tmax, t1/2 of midazolam
10 Days
Vital signs, laboratory tests and adverse events
10 Days
Study Arms (2)
Treatment Sequence 1
EXPERIMENTALTreatment Sequence 2
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- Healthy male and/or female (non-child bearing potential) subjects
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
August 13, 2009
Record last verified: 2009-08