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NCT00447629 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00447629
Other study ID # 3180A1-1109
Secondary ID
Status Completed
Phase Phase 1
First received March 14, 2007
Last updated December 3, 2007
Start date January 2007
Est. completion date March 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• PPM-204

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Secondary Pharmacokinetics
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