Status:

COMPLETED

A Single Dose Study Of PF-05161704 In Healthy Volunteers

Lead Sponsor:

Pfizer

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.

Eligibility Criteria

Inclusion

  • Healthy male and/or female (non child-bearing potential) 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).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening or positive cotinine test at screening or Day 0 of period one

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT01183715

Start Date

July 1 2010

End Date

September 1 2010

Last Update

July 23 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Pfizer Investigational Site

New Haven, Connecticut, United States, 06511