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Trial record 1 of 1 for:    NCT01433380
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A Study To Evaluate PF-05175157 In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01433380
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 23, 2011
First Posted Date  ICMJE September 13, 2011
Last Update Posted Date May 18, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
Changes in carbohydrate and lipid metabolism [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01433380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
Pharmacokinetics: 0.5, 1, 1.5, 2.5, 6.5, 10.5, 24 hrs after dosing, parameters: Cmax, Tmax and Area under the Curve (AUC) [ Time Frame: 24 hours ]
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 A Study To Evaluate PF-05175157 In Healthy Volunteers
Official Title  ICMJE Phase 1 Study To Evaluate The Effect Of Single Doses Of Pf-05175157 On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
Brief Summary The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of PF-05175157 in healthy volunteers
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)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: PF-05175157
    One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
  • Drug: Placebo
    One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Study Arms  ICMJE
  • Experimental: 600 mg PF-05175157
    Subjects will receive one dose of PF-05175157. The sequence of receiving 600 mg PF-05175157 or placebo will be randomized.
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Subjects will receive one dose of placebo. The sequence of receiving placebo or 600 mg PF-05175157 will be randomized.
    Intervention: Drug: Placebo
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: May 16, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2011)
20
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female 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.
  • In addition, subjects must have normal pulmonary function tests and normal ocular examination.
  • Body Mass Index of 20.0 35.0 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0.
  • Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01433380
Other Study ID Numbers  ICMJE B1731004
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 May 2012

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