Cardiac Safety of Indacaterol

Phase 1CompletedNCT01263808

Novartis Pharmaceuticals404 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

404

Conditions

Healthy Volunteers Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol 150 µgDRUG

Once daily (QD) via single-dose dry powder inhaler (SDDPI)

Indacaterol 300 µgDRUG

QD via SDDPI

Indacaterol 600 µgDRUG

QD via SDDPI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Novartis investigative site

Miami, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in QTc interval (Fridericia's)

Time frame: Change from baseline (prior to the first dose) to Day 14

Secondary Outcomes

Change from baseline in uncorrected QT interval

Time frame: Change from baseline (prior to the first dose) to Day 14

Data from ClinicalTrials.gov

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