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A Study Of PF-04620110 As A Modified-Release Formulation In Healthy Overweight Or Obese Subjects

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ClinicalTrials.gov Identifier: NCT01474941
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE November 18, 2011
Last Update Posted Date January 26, 2012
Study Start Date  ICMJE June 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes fro baseline in pulse rate, blood pressure and ECG measurements over 14 days. [ Time Frame: 2 weeks ]
  • Profile of Pharmacokinetics: timeframe 0, 0.5, 1,2.5, 4.5, 6.5, 8.5, 10, 10.5, 11, 12.5, 14.5, 16.5 and 24 hr on Days 1 and 14. 24, 48, 72, 96, 120, 144 and 216 hrs post first dosing [ Time Frame: 2 weeks ]
  • PK parameters: Area under the Concentration-Time Curve (AUC), Maximum Observed Plasma Concentration (Cmax), Time to Reach Maximum Observed Plasma Concentration (Tmax), Apparent Oral Clearance (CL/F), Accumulation Ratios (Cmax,ss/Cmin,ss, AUC [ Time Frame: 2 weeks ]
  • (0-24,ss)/AUC(0-24,sd) andCmax,ss/Cmax,sd) [ Time Frame: 2 weeks ]
  • Glucose response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average glucose on Days 0 and 14; fasting plasma glucose [ Time Frame: 2 weeks ]
  • Insulin response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average insulin on Days 0 and 14; fasting plasma insulin [ Time Frame: 2 weeks ]
  • total GLP-1 response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average total GLP-1 on Days 0 and 14; fasting total GLP-1 [ Time Frame: 2 weeks ]
  • net triglycerides response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average net triglycerides on Days 0 and 14; fasting plasma net triglycerides [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2011)
  • Safety and tolerability: Adverse event monitoring, daily fecal assessment, clinical safety laboratory tests, vital signs, physical exams, 12 lead ECG. [ Time Frame: 2 weeks ]
  • Pharmacokinetic (PK) endpoints: Cmax, Tmax, AUC(0-24), Cmin, CL/F, Cmax,ss/Cmin,ss, AUC (0-24,ss)/AUC(0-24,sd) and Cmax,ss/Cmax,sd. [ Time Frame: 2 weeks ]
  • Pharmacodynamic (PD) endpoints: 24-hour, post-MMTT, post-lunch and post-dinner weighted mean average of plasma glucose, insulin, total GLP-1 and net triglycerides; fasting plasma glucose, insulin, total GLP-1 and net triglycerides. [ Time Frame: 2 weeks ]
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 Of PF-04620110 As A Modified-Release Formulation In Healthy Overweight Or Obese Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Parallel, Placebo-Controlled, Multiple-Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of A Modified-Release Formulation Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects
Brief Summary The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.
Detailed Description To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04620110 or Placebo
    Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks
  • Drug: PF-04620110 or Placebo
    Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks
  • Drug: PF-04620110 or Placebo
    Repeat Arm 1 or Arm 2
Study Arms  ICMJE
  • Experimental: 5 mg QD PF-04620110 or Placebo
    Intervention: Drug: PF-04620110 or Placebo
  • Experimental: 5 mg BID PF-04620110 or Placebo
    Intervention: Drug: PF-04620110 or Placebo
  • Experimental: Optional Arm, PF-04620110 or Placebo
    Intervention: Drug: PF-04620110 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 Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2011)
27
Original Actual 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 and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 27 to 35 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474941
Other Study ID Numbers  ICMJE B0961011
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