Clinical Trial: Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics of 600 µg Indacaterol in Subjects With Impaired Hepatic Function in Comparison With Healthy Control Subjects

Brief Summary: This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in subjects with impaired liver function in comparison with healthy subjects

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Pharmacokinetic assessments of orally inhaled indacaterol will be made for up to 168 hours post dose for healthy subjects and for up to 240 hours post dose for patients with mild to moderate liver impairment.

Original Primary Outcome: Same as current

Current Secondary Outcome: General tolerability and safety indacaterol administered by oral inhalation in the study groups. Safety assessments will include physical examinations, ECGs, vital signs, adverse events, and laboratory evaluations.

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 27, 2006
Date Started: November 2006
Date Completion:
Last Updated: June 9, 2008
Last Verified: June 2008