NCT02171832

Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Pharmacokinetics, Safety and Tolerability of a Single Dose of BI 1744 CL (20 μg Administered With the Respimat® Inhaler) in Patients With Mild and Moderate Hepatic Impairment (Child Pugh Classifications A and B) in Comparison to a Single Dose of BI 1744 CL (30 μg Administered With the Respimat® Inhaler) in Subjects With Normal Hepatic Function in a Monocentric, Open Label, Parallel Group Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with normal hepatic function after single orally inhaled administration of BI 1744 CL with the Respimat® Inhaler.

Conditions

• Healthy
• Liver Diseases

Interventions

Type	Name	Description
DRUG	BI 1744 CL, low dose
DRUG	BI 1744 CL, high dose

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-01
• First posted: 2014-06-24
• Last updated: 2014-06-24