Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00331175
Previous Study | Return to List | Next Study

Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331175
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : December 15, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 26, 2006
First Posted Date  ICMJE May 29, 2006
Last Update Posted Date December 15, 2006
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
Food intake
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
Plasma biomarkers, safety, toleration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Peptide YY3-36
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 26, 2006)
31
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 27-35 kg/m2

Exclusion Criteria:

  • Women of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00331175
Other Study ID Numbers  ICMJE A9001292
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP