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

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00447629

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 I

MedlinePlus related topics: Diabetes

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
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:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Eligibility

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

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

Study placed in the following topic categories:

Metabolic Diseases
Moxifloxacin
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009