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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Obesity Overweight Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04620110

Group Type EXPERIMENTAL

PF-04620110

Intervention Type DRUG

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.

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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PF-04620110

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes