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Trial record 1 of 1 for:    NCT01469481
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Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

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ClinicalTrials.gov Identifier: NCT01469481
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 28, 2011
First Posted Date  ICMJE November 10, 2011
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
  • Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. [ Time Frame: 0-168 hrs ]
  • Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces. [ Time Frame: 0-168 hrs ]
  • radioactivity AUC [ Time Frame: 0-168 hrs ]
  • plasma PF-04991532 AUC [ Time Frame: 0-168 hrs ]
  • radioactivity Cmax [ Time Frame: 0-168 hrs ]
  • plasma PF-04991532 Cmax [ Time Frame: 0-168 hrs ]
  • plasma PF-04991532 Tmax [ Time Frame: 0-168 hrs ]
  • radioactivity Tmax [ Time Frame: 0-168 hrs ]
  • plasma PF-04991532 t1/2 [ Time Frame: 0-168 hrs ]
  • radioactivity t1/2 [ Time Frame: 0-168 hrs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532
Official Title  ICMJE An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
Brief Summary The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of [14C]PF-04991532 in healthy adult male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: PF-04991532
a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-04991532
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 8, 2011)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg(110 lbs).
  • An informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
  • History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
  • Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 NCT01469481
Other Study ID Numbers  ICMJE B2611007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2012

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