NCT01298063

Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

Pharmacokinetics, Safety and Tolerability of Different Oral Doses of Afatinib, in Subjects With Mild to Moderate Hepatic Impairment Compared to Healthy Subjects - a Phase I, Single-dose, Open-label, Dose-escalation Study in a Matched Group Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.

Conditions

• Liver Diseases
• Healthy

Interventions

Type	Name	Description
DRUG	Afatinib	1 tablet, once qd in the morning
DRUG	Afatinib	1 tablet, once qd in the morning
DRUG	Afatinib	1 tablet, once qd in the morning

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• First posted: 2011-02-17
• Last updated: 2013-12-31
• Results posted: 2013-10-17

Locations

1 site across 1 country: Germany