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Trial record 1 of 1 for:    NCT01247896
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Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01247896
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 23, 2010
First Posted Date  ICMJE November 24, 2010
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements [ Time Frame: 8 weeks ]
  • The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit [ Time Frame: 48 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01247896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
  • PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), [ Time Frame: 48 hour ]
  • Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC) [ Time Frame: Day 1 for Periods 1 and 2, for Cohort 3. ]
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 Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
Official Title  ICMJE A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects
Brief Summary PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose 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: Treatment
Condition  ICMJE Diabetes Mellitus, Type II
Intervention  ICMJE
  • Drug: PF-05190457
    Single Dose 2 mg
  • Drug: PF-05190457
    Single Dose 10 mg
  • Drug: PF-05190457
    Single Dose 30 mg
  • Drug: PF-05190457
    Single Dose 100 mg
  • Drug: PF-05190457
    Single Dose 300 mg
  • Drug: PF-05190457
    Single Dose 600 mg
  • Drug: PF-05190457
    Single Dose - to be determined with food
  • Drug: PF-05190457
    Single Dose - to be determined
  • Drug: Placebo
    Single Dose Placebo
Study Arms  ICMJE
  • Experimental: Active
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
  • Placebo Comparator: Placebo
    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
Estimated Enrollment  ICMJE
 (submitted: November 23, 2010)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic 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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01247896
Other Study ID Numbers  ICMJE B3301001
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 July 2011

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