Conditions: Liver Diseases Healthy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: healthy subjects, mild and moderate liver impaired subjects to receive one single dose treatment containing the highest dose afatinib arm 2: healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the medium dose of afatinib arm 3: healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the low dose of afatinib

Interventions: intervention 1: Afatinib intervention 2: Afatinib intervention 3: Afatinib
Intervention descriptions: intervention 1: 1 tablet, once qd in the morning intervention 2: 1 tablet, once qd in the morning intervention 3: 1 tablet, once qd in the morning

Protocol document: