Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
1 other identifier
interventional
12
1 country
1
Brief Summary
The current study is designed to estimate the effect of rifampin (600 mg orally every 24 hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Sep 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedOctober 22, 2010
October 1, 2010
1 month
September 15, 2010
October 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUCinf of tasocitinib (CP-690,550)
9 days
Cmax of tasocitinib (CP-690,550)
9 days
Secondary Outcomes (2)
AUClast, Tmax, t1/2 of tasocitinib (CP-690,550)
9 days
Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate).
9 days
Study Arms (1)
Tasocitinib (CP-690,550) plus Rifampin
EXPERIMENTALInterventions
Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects (of non-childbearing potential)
You may not qualify if:
- Clinically significant disease or condition
- Recent serious infection
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
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 17, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 22, 2010
Record last verified: 2010-10