You are here

A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 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 male and/or female subjects between the ages of 18 and 55 years, inclusive.

- Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must
have normal pulmonary function tests and normal ocular findings.

- Women must be of non-childbearing potential.

- Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110
lbs).

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,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic
disease (including drug allergies and seasonal allergies at time of dosing).

- Evidence or history of any chronic ongoing or current pulmonary disease.

- History of smoking in the past 5 years or history or evidence of habitual use of
other (non smoked) tobacco or nicotine-containing products within 3 months of
Screening or positive cotinine test at Screening or Day -7.

- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye
symptoms or retinal/optic nerve disease.

NCT01537497
Pfizer
Completed
A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Type 2 Diabetes Mellitus
NCT03985293
All Genders
18+
Years
Multiple Sites
Type 2 Diabetes Mellitus
NCT03538743
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers
Official Title  ICMJE Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
Brief SummaryThe primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers
Detailed DescriptionNot 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-05175157
    One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
  • Drug: Placebo
    One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Study Arms  ICMJE
  • Experimental: 100 mg PF-05175157
    The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
    Intervention: Drug: PF-05175157
  • Experimental: 250 mg PF-05175157
    The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
    Intervention: Drug: PF-05175157
  • Experimental: 600 mg PF-05175157
    The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
    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
Actual Enrollment  ICMJE
 (submitted: July 6, 2012)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2012)
32
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateMay 2012   (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.
  • Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
  • Women must be of non-childbearing potential.
  • Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -7.
  • Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01537497
Other Study ID Numbers  ICMJE B1731013
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 DateJuly 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

Call Now