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Corrected QT (QTc) Study With Flucticasone Furoate and GW642444
A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in healthy male and female subjects. Key assessments will include 12- lead electrocardiogram (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 85 |
| Start date | Wed Jun 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jan 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Asthma
Interventions
- Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination
- Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination
- Placebo Inhaler
- Moxifloxacin 400mg
- Moxifloxacin placebo
Countries
United Kingdom