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Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01204112
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 15, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date October 22, 2010
Study Start Date  ICMJE September 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • AUCinf of tasocitinib (CP-690,550) [ Time Frame: 9 days ]
  • Cmax of tasocitinib (CP-690,550) [ Time Frame: 9 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • AUClast, Tmax, t1/2 of tasocitinib (CP-690,550) [ Time Frame: 9 days ]
  • Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate). [ Time Frame: 9 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Tasocitinib (CP-690,550) plus Rifampin
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)
Study Arms  ICMJE Experimental: Tasocitinib (CP-690,550) plus Rifampin
Intervention: Drug: Tasocitinib (CP-690,550) plus Rifampin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects (of non-childbearing potential)

Exclusion Criteria:

  • Clinically significant disease or condition
  • Recent serious infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01204112
Other Study ID Numbers  ICMJE A3921056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP