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Trial record 1 of 1 for:    NCT00797342
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A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00797342
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date May 5, 2009
Study Start Date  ICMJE December 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
  • Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve [ Time Frame: 2 weeks ]
  • Safety/Tolerability e.g., reported adverse events and safety laboratory studies [ Time Frame: 2 weeks ]
  • Pharmacodynamics e.g., changes in a peripheral blood biomarker [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
  • Safety/Tolerability e.g., reported adverse events and safety laboratory studies [ Time Frame: 2 weeks ]
  • Pharmacodynamics e.g., changes in a peripheral blood blood biomarker [ Time Frame: 2 weeks ]
  • Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00797342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers
Brief Summary This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-04629991
    Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
  • Drug: PF-04629991
    Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
  • Drug: PF-04629991
    Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)
Study Arms  ICMJE
  • first of three dosing cohorts
    Intervention: Drug: PF-04629991
  • second of three dosing cohorts
    Intervention: Drug: PF-04629991
  • third of three dosing cohorts
    Intervention: Drug: PF-04629991
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: November 24, 2008)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy non-smoking men and women
  • body mass index 18-30 kg/m2

Exclusion Criteria:

  • Women must not be able to have children
  • no current infections
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797342
Other Study ID Numbers  ICMJE B0881001
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 May 2009

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