Overview
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
PfizerTreatments:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Criteria
Inclusion Criteria:- 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 Criteria:
- 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