A Single Dose Study Of PF-05161704 In Healthy Volunteers

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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: PF-05161704 or placebo
* Drug: PF-05161704 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Drug: PF-05161704 or placebo<br>* PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension<br>|
| Experimental: Cohort 2<br>Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3 | Drug: PF-05161704 or placebo<br>* PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary pharmacodynamics of PF-05161704 |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects