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Cardiac Safety of Indacaterol

A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01263808
Enrollment
404
Registered
2010-12-21
Start date
2008-04-30
Completion date
Unknown
Last updated
2010-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Chronic Obstructive Pulmonary Disease

Keywords

Indacaterol, Moxifloxacin

Brief summary

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

Interventions

DRUGIndacaterol 600 µg

QD via SDDPI

DRUGPlacebo

QD via SDDPI

DRUGPlacebo/moxifloxacin

Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg

DRUGIndacaterol 150 µg

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

DRUGIndacaterol 300 µg

QD via SDDPI

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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/

Design outcomes

Primary

MeasureTime frame
Change from baseline in QTc interval (Fridericia's)Change from baseline (prior to the first dose) to Day 14

Secondary

MeasureTime frame
Change from baseline in uncorrected QT intervalChange from baseline (prior to the first dose) to Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026