A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

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, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.

Official Title
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A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Multiple Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Adult Subjects

Conditions
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Obesity, Overweight, Healthy

Intervention / Treatment
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* 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 PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.<br>|
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. |  | Day -1 and Day 14 | 
| Secondary Pharmacodynamic Endpoints in response to a liquid meal test |  | Day -1 and Day 14 | 
| Triglyceride excursions |  | Day -1, Day 1, and Day 14 | 
| Glucose, insulin, and C-peptide excursions |  | Day -1 and Day 14 | 
| Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY |  | Day -1 and Day 14 | 
| Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin |  | Day -1 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms