A Study Of PF-04620110 As A Modified-Release Formulation In Healthy Overweight Or Obese Subjects

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-08-31

Brief Summary

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The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

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Detailed Description

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To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5 mg QD PF-04620110 or Placebo

Group Type EXPERIMENTAL

PF-04620110 or Placebo

Intervention Type DRUG

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks

5 mg BID PF-04620110 or Placebo

Group Type EXPERIMENTAL

PF-04620110 or Placebo

Intervention Type DRUG

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks

Optional Arm, PF-04620110 or Placebo

Group Type EXPERIMENTAL

PF-04620110 or Placebo

Intervention Type DRUG

Repeat Arm 1 or Arm 2

Interventions

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PF-04620110 or Placebo

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks

Intervention Type DRUG

PF-04620110 or Placebo

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks

Intervention Type DRUG

PF-04620110 or Placebo

Repeat Arm 1 or Arm 2

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, inclusive.
* Body Mass Index (BMI) of 27 to 35 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