Cardiac Safety of Indacaterol

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Chronic Obstructive Pulmonary Disease

Treatments: Drug: Indacaterol 300 µg; Drug: Placebo/moxifloxacin; Drug: Indacaterol 600 µg; Drug: Indacaterol 150 µg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263808

CQAB149B2339

Details and patient eligibility

About

This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.

Enrollment: 404 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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404 participants in 5 patient groups, including a placebo group

Indacaterol 150 µg

Experimental group

Description:

Indacaterol 150 µg

Treatment:

Drug: Indacaterol 150 µg

Indacaterol 300 µg

Experimental group

Description:

Indacaterol 300 µg

Treatment:

Drug: Indacaterol 300 µg

Indacaterol 600 µg

Experimental group

Description:

Indacaterol 600 µg

Treatment:

Drug: Indacaterol 600 µg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Placebo/moxifloxacin

Active Comparator group

Description:

Placebo/moxifloxacin

Treatment:

Drug: Placebo/moxifloxacin