A Single Dose Study Of PF-05161704 In Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PF-05161704 or placebo

• Registration Number: NCT01183715
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-18
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 2	PF-05161704 or placebo	Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3
Cohort 1	PF-05161704 or placebo	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.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects	1 month
Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145	1 month

Secondary Outcome Measures

Name	Time	Method
Preliminary pharmacodynamics of PF-05161704	1 month

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States