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Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01185184
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 18, 2010
First Posted Date  ICMJE August 19, 2010
Last Update Posted Date September 14, 2010
Study Start Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550 [ Time Frame: 36 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01185184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550 [ Time Frame: 9 days ]
  • Safety: laboratory tests, adverse events reporting, ECG and vital signs [ 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 Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550
Brief Summary This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: CP-690,550
Single doses separated by a minimum of 72 hour washout between treatments
Study Arms  ICMJE Experimental: 1
Subjects will receive in random order, the immediate release tablet containing 10 mg of CP-690,550 and two different controlled-release capsules containing 20 mg of CP-690,550.
Intervention: Drug: CP-690,550
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: August 18, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Clinically significant infections within the past 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Months to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01185184
Other Study ID Numbers  ICMJE A3921113
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 September 2010

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