ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00447629
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: PPM-204 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : January 2007
Actual Study Completion Date : March 2007



Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Pharmacokinetics


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00447629     History of Changes
Other Study ID Numbers: 3180A1-1109
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

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