Cardiac Safety of Indacaterol
Phase 1
Completed
- Conditions
- Healthy VolunteersChronic Obstructive Pulmonary Disease
- Interventions
- Drug: PlaceboDrug: Placebo/moxifloxacin
- Registration Number
- NCT01263808
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
Inclusion Criteria
- Healthy, non-smoking
- Body mass index (BMI) 18.5-32 kg/m2
- Body weight at least 50 kg
Exclusion Criteria
- Recent/concurrent use of concomitant medications (except acetaminophen)
- Recent participation in other clinical trials
- Recent donation or loss of blood
- History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indacaterol 150 µg Indacaterol 150 µg Indacaterol 150 µg Indacaterol 300 µg Indacaterol 300 µg Indacaterol 300 µg Indacaterol 600 µg Indacaterol 600 µg Indacaterol 600 µg Placebo Placebo Placebo Placebo/moxifloxacin Placebo/moxifloxacin Placebo/moxifloxacin
- Primary Outcome Measures
Name Time Method Change from baseline in QTc interval (Fridericia's) Change from baseline (prior to the first dose) to Day 14
- Secondary Outcome Measures
Name Time Method Change from baseline in uncorrected QT interval Change from baseline (prior to the first dose) to Day 14
Trial Locations
- Locations (1)
Novartis investigative site
🇺🇸Miami, Florida, United States