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A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

PF-04620110

Placebo

About this trial

This is an interventional treatment trial for Healthy focused on measuring Multiple Dose Study in Overweight Healthy Subjects, body weight

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

To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.

Secondary Outcome Measures

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

To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.

Full Information

NCT ID

NCT01146327

First Posted

June 16, 2010

Last Updated

April 18, 2011

Sponsor

Pfizer

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01146327

Brief Title

A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

Official Title

A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (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, 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

Healthy

Keywords

Multiple Dose Study in Overweight Healthy Subjects, body weight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

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 5 mg of PF-04620110 will be given once daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-04620110

Intervention Description

Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-04620110

Intervention Description

Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

PF-04620110

Intervention Description

Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Multiple oral doses of placebo will be given once daily for 2 weeks.

Primary Outcome Measure Information:

Title

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

Time Frame

Day 1 to Day 13

Title

To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.

Time Frame

Day 6 and Day 14

Secondary Outcome Measure Information:

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 assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.

Time Frame

Baseline to 2 weeks

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

Bruxelles

ZIP/Postal Code

B-1070

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0961010&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-04620110%20In%20Healthy%20Overweight%20Or%20Obese%20Subjects

Description

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A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

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