Back to resultsA Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
Primary Purpose
Overweight
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
PF-04620110
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Single Ascending Dose Study in Overweight subjects
Eligibility Criteria
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) of approximately 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PF-04620110
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, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
The single dose pharmacokinetics of PF-04620110 will be assessed
Secondary Outcome Measures
Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00799006
Brief Title
A Single 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 Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Single Ascending Dose Study in Overweight subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PF-04620110
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will be given placebo or PF-04620110
Intervention Type
Drug
Intervention Name(s)
PF-04620110
Intervention Description
A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.
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, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
Time Frame
4 days/dose group
Title
The single dose pharmacokinetics of PF-04620110 will be assessed
Time Frame
4 days/dose group
Secondary Outcome Measure Information:
Title
Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures
Time Frame
1 day/dose group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
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 approximately 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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=B0961001&StudyName=A%20Single%20Dose%20Study%20Of%20PF-04620110%20In%20Overweight%20And%20Obese%2C%20Otherwise%20Healthy%20Volunteers
Description
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Learn more about this trial
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
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