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Cardiac Safety of Indacaterol

Primary Purpose

Healthy Volunteers, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Indacaterol 150 µg

Indacaterol 300 µg

Indacaterol 600 µg

Placebo

Placebo/moxifloxacin

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring Indacaterol, Moxifloxacin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Novartis investigative site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Indacaterol 150 µg

Indacaterol 300 µg

Indacaterol 600 µg

Placebo

Placebo/moxifloxacin

Arm Description

Indacaterol 150 µg

Indacaterol 300 µg

Indacaterol 600 µg

Placebo

Placebo/moxifloxacin

Outcomes

Primary Outcome Measures

Change from baseline in QTc interval (Fridericia's)

Secondary Outcome Measures

Change from baseline in uncorrected QT interval

Full Information

NCT ID

NCT01263808

First Posted

December 17, 2010

Last Updated

December 20, 2010

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01263808

Brief Title

Cardiac Safety of Indacaterol

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Chronic Obstructive Pulmonary Disease

Keywords

Indacaterol, Moxifloxacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indacaterol 150 µg

Arm Type

Experimental

Arm Description

Indacaterol 150 µg

Arm Title

Indacaterol 300 µg

Arm Type

Experimental

Arm Description

Indacaterol 300 µg

Arm Title

Indacaterol 600 µg

Arm Type

Experimental

Arm Description

Indacaterol 600 µg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Placebo/moxifloxacin

Arm Type

Active Comparator

Arm Description

Placebo/moxifloxacin

Intervention Type

Drug

Intervention Name(s)

Indacaterol 150 µg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Indacaterol 300 µg

Intervention Description

QD via SDDPI

Intervention Type

Drug

Intervention Name(s)

Indacaterol 600 µg

Intervention Description

QD via SDDPI

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

QD via SDDPI

Intervention Type

Drug

Intervention Name(s)

Placebo/moxifloxacin

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in QTc interval (Fridericia's)

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline in uncorrected QT interval

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis investigative site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21615886

Citation

Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31.

Results Reference

derived

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Cardiac Safety of Indacaterol

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