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Completed

NCT Number: NCT00447629

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, 85044, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPM-204

Drug

Primary outcomes

  1. Safety

Secondary outcomes

  1. Pharmacokinetics

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
Mar 15, 2007
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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