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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014