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

Pfizer71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity Overweight Healthy

Interventions

PF-04620110DRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 2 weeks

To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.

Time frame: Baseline to 2 weeks

To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.

Time frame: Baseline to 2 weeks

Secondary Outcomes

To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.

Time frame: Day -1 and Day 14

Secondary Pharmacodynamic Endpoints in response to a liquid meal test

Time frame: Day -1 and Day 14

Triglyceride excursions

Time frame: Day -1, Day 1, and Day 14

Glucose, insulin, and C-peptide excursions

Time frame: Day -1 and Day 14

Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY

Time frame: Day -1 and Day 14

Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin

Time frame: Day -1 and Day 14

Data from ClinicalTrials.gov

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