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

Primary Purpose

Obesity, Overweight, Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04620110

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring - Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04620110

Placebo Comparator

Arm Description

Outcomes

Primary Outcome Measures

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.

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

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

Secondary Outcome Measures

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

Secondary Pharmacodynamic Endpoints in response to a liquid meal test

Triglyceride excursions

Glucose, insulin, and C-peptide excursions

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

Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin

Full Information

NCT ID

NCT00959426

First Posted

August 12, 2009

Last Updated

June 3, 2010

Sponsor

Pfizer

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00959426

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight, Healthy

Keywords

- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04620110

Arm Type

Experimental

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-04620110

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

Baseline to 2 weeks

Title

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

Time Frame

Baseline to 2 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Day -1 and Day 14

Title

Secondary Pharmacodynamic Endpoints in response to a liquid meal test

Time Frame

Day -1 and Day 14

Title

Triglyceride excursions

Time Frame

Day -1, Day 1, and Day 14

Title

Glucose, insulin, and C-peptide excursions

Time Frame

Day -1 and Day 14

Title

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

Time Frame

Day -1 and Day 14

Title

Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin

Time Frame

Day -1 and Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0961002&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-04620110%20In%20Overweight%20And%20Obese%2C%20Otherwise%20Healthy%20Volunteers

Description

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

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