You are here

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

Last updated on May 9, 2018

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

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 zip code, city, or country to find studies near you.

Similar Trials

Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
NCT02573259
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Type 1 Diabetes Mellitus
NCT02038764
All Genders
18+
Years
Multiple Sites
A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers
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
The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01537497
B1731013
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now