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Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00447629
First received: March 14, 2007
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.


Condition Intervention Phase
Diabetes Mellitus
 Drug: PPM-204
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)- Controlled, 4-Period Crossover Study of the Effects of Single Oral Doses of PPM 204 on Cardiac Repolarization in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Pharmacokinetics

Study Start Date: January 2007
Study Completion Date: March 2007
  Eligibility

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

Inclusion Criteria:

  • Men or women, aged 18 to 55 years
  • Body mass index in the range of 18 to 30 kg/m2
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG

Exclusion Criteria:

  • History of cardiac, thyroid, muscle, or kidney abnormalities
  • A family history of long QT syndrome and/or sudden cardiac death
  • History of any clinically significant drug allergy, hypersensitivity to sulfonomides or the quinolone class of antibiotics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447629

Locations
United States, Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447629     History of Changes
Other Study ID Numbers: 3180A1-1109
Study First Received: March 14, 2007
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013