Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2007
Shorter than P25 for phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 14, 2007
CompletedFirst Posted
Study publicly available on registry
March 15, 2007
CompletedDecember 5, 2007
December 1, 2007
March 14, 2007
December 3, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Secondary Outcomes (1)
Pharmacokinetics
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Phoenix, Arizona, 85044, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2007
First Posted
March 15, 2007
Study Start
January 1, 2007
Study Completion
March 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12