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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00331175
First received: May 26, 2006
Last updated: December 14, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Peptide YY3-36
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Food intake

Secondary Outcome Measures:
  • Plasma biomarkers, safety, toleration

Estimated Enrollment: 31
Study Start Date: July 2006
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 27-35 kg/m2

Exclusion Criteria:

  • Women of childbearing potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331175

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00331175     History of Changes
Other Study ID Numbers: A9001292
Study First Received: May 26, 2006
Last Updated: December 14, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014