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Trial record 1 of 1 for:    NCT01372163
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A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01372163
Recruitment Status : Terminated (B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.)
First Posted : June 13, 2011
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 10, 2011
First Posted Date  ICMJE June 13, 2011
Last Update Posted Date May 23, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2011)
Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT01372163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2011)
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ]
  • Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit. [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • 1. The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ]
  • Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit. [ Time Frame: 2 weeks ]
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-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
Official Title  ICMJE A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Doses Of PF-05190457 In Healthy And Type 2 Diabetic Adults
Brief Summary The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: PF-05190457 or Placebo
    Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
  • Drug: PF-05190457 or Placebo
    Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
  • Drug: PF-05190457 or Placebo
    Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.
Study Arms  ICMJE
  • Experimental: 2 mg PF-05190457 or Placebo BID
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: 10 mg PF-05190457 or Placebo BID
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: 40 mg PF-05190457 or Placebo BID
    Dose and dose frequency may be adjusted based on emerging safety and PK data.
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: 150 mg PF-05190457 or Placebo BID
    Dose and dose frequency may be adjusted based on emerging safety and PK data.
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: 5 mg PF-05190457 or Placebo QD
    Dose and dose frequency may be adjusted based on emerging safety and PK data.
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: 50 mg PF-05190457 or Placebo QD
    Dose and dose frequency may be adjusted based on emerging safety and PK data.
    Intervention: Drug: PF-05190457 or Placebo
  • Experimental: xxx mg PF-05190457 or Placebo
    Dose and dose frequency to be determined based on emerging safety and PK data.
    Intervention: Drug: PF-05190457 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: May 16, 2012)
35
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
63
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
  • Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
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 NCT01372163
Other Study ID Numbers  ICMJE B3301002
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