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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: PPM-204

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447629

3180A1-1109

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind