Status:
COMPLETED
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
Eligibility Criteria
Inclusion
- Healthy male and female subjects aged 18 to 55 years
- Body mass Index of approximately 18 to 30kg/m2
- Informed consent document signed by the subject or a legally acceptable representative
- Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures
Exclusion
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
- Conditions possibly affecting drug absorption
- 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
- Positive urine drug screen
- Hypersensitivity to moxifloxacin
- Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00809289
Start Date
December 1 2008
End Date
July 1 2009
Last Update
April 7 2011
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070