Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart
Phase 1
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00447629
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Pharmacokinetics