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Trial record 1 of 1 for:    NCT01165736
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To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165736
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 16, 2010
First Posted Date  ICMJE July 20, 2010
Last Update Posted Date August 24, 2010
Study Start Date  ICMJE July 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
  • Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry) [ Time Frame: up to 3 days post dose ]
  • pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve [ Time Frame: up to 3 days post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry) [ Time Frame: up to 3 days post dose ]
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 To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity
Official Title  ICMJE An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects
Brief Summary The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-05186462
    single intravenous infusion of 100 microgram
  • Drug: PF-05186462
    single oral administration of 100 microgram
  • Drug: PF-05089771
    single intravenous infusion of 100 microgram of PF-05089771
  • Drug: PF-05089771
    single oral administration of 100 microgram PF-05089771
  • Drug: PF-05150122
    single intravenous administration of 100 microgram PF-05150122
  • Drug: PF-05150122
    single oral administration of 100 microgram PF-05150122
  • Drug: PF-05241328
    single intravenous infusion of 100 microgram PF-05241328
  • Drug: PF-05241328
    single oral administration 100 microgram PF-05241328
Study Arms  ICMJE
  • Active Comparator: Intravenous: PF-05186462
    Intervention: Drug: PF-05186462
  • Active Comparator: Oral: PF-05186462
    Intervention: Drug: PF-05186462
  • Active Comparator: Intravenous: PF-05089771
    Intervention: Drug: PF-05089771
  • Active Comparator: Oral: PF-05089771
    Intervention: Drug: PF-05089771
  • Active Comparator: Intravenous: PF-05150122
    Intervention: Drug: PF-05150122
  • Active Comparator: Oral: PF-05150122
    Intervention: Drug: PF-05150122
  • Active Comparator: Intravenous: PF-05241328
    Intervention: Drug: PF-05241328
  • Active Comparator: Oral: PF-05241328
    Intervention: Drug: PF-05241328
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: July 16, 2010)
40
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 subjects between the ages of 18 and 50 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 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

  • Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
  • History of febrile illness within 5 days prior to the first dose a positive urine drug screen
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 Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01165736
Other Study ID Numbers  ICMJE B3071001
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 August 2010

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