Cardiac Safety of Indacaterol

NCT01263808 | Completed Phase 1

• 1 other identifier: CQAB149B2339
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers; Chronic Obstructive Pulmonary Disease

Keywords

Indacaterol; Moxifloxacin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QTc interval (Fridericia's)

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

Secondary Outcomes (1)

• Change from baseline in uncorrected QT interval

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

Study Arms (5)

Indacaterol 150 µg

EXPERIMENTAL

Indacaterol 150 µg

Drug: Indacaterol 150 µg

Indacaterol 300 µg

EXPERIMENTAL

Indacaterol 300 µg

Drug: Indacaterol 300 µg

Indacaterol 600 µg

EXPERIMENTAL

Indacaterol 600 µg

Drug: Indacaterol 600 µg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Placebo/moxifloxacin

ACTIVE COMPARATOR

Placebo/moxifloxacin

Drug: Placebo/moxifloxacin

Interventions

Indacaterol 150 µg DRUG

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

Indacaterol 150 µg

Indacaterol 300 µg DRUG

QD via SDDPI

Indacaterol 300 µg

Indacaterol 600 µg DRUG

QD via SDDPI

Indacaterol 600 µg

Placebo DRUG

QD via SDDPI

Placebo

Placebo/moxifloxacin DRUG

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

Placebo/moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking
• Body mass index (BMI) 18.5-32 kg/m2
• Body weight at least 50 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis investigative site

Miami, Florida, 33126, United States

Location

Related Publications (1)

• 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.

  PMID: 21615886 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Moxifloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: December 21, 2010

Record last verified: 2010-12

Locations

US (1)