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

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

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

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

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
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 identifier: NCT00447629

United States, Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information 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 processed this record on May 22, 2016