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Trial record 1 of 1 for:    NCT01408355
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A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

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ClinicalTrials.gov Identifier: NCT01408355
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date September 9, 2011
Study Start Date  ICMJE July 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
  • The number of participants with Adverse Events as a measure of Safety and tolerability. [ Time Frame: 3 days ]
  • Pharmacokinetics : peak plasma concentration [ Time Frame: 3 days ]
  • Pharmacokinetics : time of peak plasma concentration [ Time Frame: 3 days ]
  • Pharmacokinetics : area under plasma concentration-time curve [ Time Frame: 3 days ]
  • Pharmacokinetics : Terminal plasma half life [ Time Frame: 3 days ]
  • Pharmacokinetics : Plasma Clearance [ Time Frame: 3 days ]
  • Pharmacokinetics : plasma volume of distribution [ Time Frame: 3 days ]
  • Pharmacokinetics : oral bioavailability [ Time Frame: 3 days ]
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 A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
Official Title  ICMJE An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects
Brief Summary To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-06273588
    Intravenous, 50 microgram, single dose
  • Drug: PF-06273588
    Oral solution, 50 microgram, single dose
Study Arms  ICMJE
  • Experimental: 50 microgram PF-06273588 intravenous
    Subjects will receive a single intravenous microdose of PF-06273588 in period one
    Intervention: Drug: PF-06273588
  • Experimental: 50 microgram PF-06273588 oral
    Subjects will receive a single oral microdose of PF-06273588 in period two
    Intervention: Drug: PF-06273588
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 1, 2011)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 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 measurements, 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).

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).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week for males.
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 NCT01408355
Other Study ID Numbers  ICMJE B4381001
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 September 2011

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