Back to resultsSafety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults
Primary Purpose
Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peptide YY3-36
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: BMI 27-35 kg/m2 Exclusion Criteria: Women of childbearing potential
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Food intake
Secondary Outcome Measures
Plasma biomarkers, safety, toleration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331175
Brief Title
Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults
Official Title
A Phase 1, Randomized, Placebo- And Positive Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Doses Of Intravenous Peptide YY3-36 In Otherwise Healthy Overweight Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to evaluate the safety and tolerability of single escalating doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when administered by intravenous infusion to otherwise healthy overweight adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
31 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Peptide YY3-36
Primary Outcome Measure Information:
Title
Food intake
Secondary Outcome Measure Information:
Title
Plasma biomarkers, safety, toleration
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:
BMI 27-35 kg/m2
Exclusion Criteria:
Women of childbearing potential
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
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001292&StudyName=Safety%2C+toleration+and+pharmacokinetics+of+single+intravenous+doses+of+Peptide+YY+in+overweight+adults
Description
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Learn more about this trial
Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults
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