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Trial record 1 of 1 for:    NCT01202266
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A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01202266
Recruitment Status : Terminated (The study was terminated on October 29, 2010 due to gastrointestinal adverse events.)
First Posted : September 15, 2010
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE September 15, 2010
Last Update Posted Date March 11, 2011
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring [ Time Frame: 2 weeks ]
  • Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145 [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL [ Time Frame: 2 weeks ]
  • Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight [ Time Frame: 2 weeks ]
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 Multiple Dose Study Of PF-05161704 In Healthy Volunteers
Official Title  ICMJE A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
Brief Summary The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
  • Drug: PF-05161704 or Placebo
    PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
Study Arms  ICMJE
  • Experimental: 5 mg PF-05161704 or Placebo
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 15 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 50 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: 150 mg PF-05161704 or Placebo
    Planned dose: may be modified based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: xx mg PF-05161704 or Placebo
    Planned dose and dosing regimen will be determined based on emerging PK and safety data.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: xxx mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 5 arms.
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: yy mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 6 arms
    Intervention: Drug: PF-05161704 or Placebo
  • Experimental: yyy mg PF-05161704 or Placebo
    Dose will be determined based on data from previous 7 arms.
    Intervention: Drug: PF-05161704 or 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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2011)
32
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2010)
96
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 24.5 to 35.5 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).
  • Any condition possibly affecting drug absorption (e.g., gastrectomy).
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
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 NCT01202266
Other Study ID Numbers  ICMJE B2911002
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 March 2011

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