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

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

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 Overview

• Status: Completed
• Conditions: Healthy; Obesity; Overweight
• Intervention / Treatment: Drug: PF-04620110; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	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.
Experimental: PF-04620110	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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, andc linical safety laboratory measurements.	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (Estimate): August 14, 2009

Study Record Updates

• Last Update Posted (Estimate): June 7, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: - Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: B0961002