NCT01274663

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

January 10, 2011

Last Update Submit

October 7, 2011

Conditions

Diabetes Mellitus, Type 2

Keywords

Single Ascending DosePhase 1Safety and TolerabilityPKHealthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects

    5 months

  • Single dose pharmacokinetics of PF-05175157

    5 months

Secondary Outcomes (1)

  • Exploratory pharmacodynamic biomarkers

    5 months

Study Arms (7)

10 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

30 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

100 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

300 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

600 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

800 mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

xxx mg PF-05175157 or Placebo

EXPERIMENTAL

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Drug: PF-05175157 or Placebo

Interventions

PF-05175157 or PlaceboDRUG

One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.

10 mg PF-05175157 or Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests.
  • In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
  • Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
  • 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 0.
  • Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
  • Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

US(1)