Cardiac Safety of Indacaterol

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263808
• Other study ID #: CQAB149B2339
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2010
• Last updated: December 20, 2010
• Start date: April 2008

Study information

• Verified date: December 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Healthy Volunteers
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 150 µg
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
• Indacaterol 300 µg
QD via SDDPI
• Indacaterol 600 µg
QD via SDDPI
• Placebo
QD via SDDPI
• Placebo/moxifloxacin
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg

Locations

Country	Name	City	State
United States	Novartis investigative site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in QTc interval (Fridericia's)		Change from baseline (prior to the first dose) to Day 14	Yes
Secondary	Change from baseline in uncorrected QT interval		Change from baseline (prior to the first dose) to Day 14	Yes