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A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01372163
Pfizer
Terminated
A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

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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 SummaryThe 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 DescriptionNot 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 DateApril 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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