A Phase 1 interventional study of Indacaterol 150 µg and Indacaterol 300 µg in Healthy Volunteers and Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-21.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 404 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Indacaterol 150 µg
Drug: Indacaterol 150 µg
Indacaterol 300 µg
Drug: Indacaterol 300 µg
Indacaterol 600 µg
Drug: Indacaterol 600 µg
Placebo
Drug: Placebo
Placebo/moxifloxacin
Drug: Placebo/moxifloxacin
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
QD via SDDPI
QD via SDDPI
QD via SDDPI
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
Change from baseline in QTc interval (Fridericia's)
Time frame: Change from baseline (prior to the first dose) to Day 14
Change from baseline in uncorrected QT interval
Time frame: Change from baseline (prior to the first dose) to Day 14
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals