A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers

Pfizer1 site in 1 country18 target enrollmentJuly 2010

ConditionsDiabetes Mellitus, Type 2

InterventionsPF-05161704 or placebo

DrugsPF-05161704 or placebo

Overview

Phase: Phase 1
Intervention: PF-05161704 or placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Pfizer
Enrollment: 18
Locations: 1
Primary Endpoint: Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

September 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Cohort 1

Subjects in Cohort 1 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-05161704 will be administered in Period 4 in the fasted state.

Intervention: PF-05161704 or placebo