A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

Study Overview
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Brief Summary
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PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.

Official Title
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A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04620110
* Drug: PF-04620110
* Drug: PF-04620110
* Drug: PF-04620110
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years Body Mass Index (BMI) of 26.5 to 35.5 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04620110<br> | Drug: PF-04620110<br>* Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.<br>Drug: PF-04620110<br>* Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.<br>Drug: PF-04620110<br>* Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.<br>Drug: PF-04620110<br>* Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.<br>|
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* Multiple oral doses of placebo will be given once daily for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. |  | Day 1 to Day 13 | 
| To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110. |  | Day 6 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects. |  | Baseline to 2 weeks | 
| To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements. |  | Baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Dose Study in Overweight Healthy Subjects, body weight