Conditions: Hepatic Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.

Detailed description:

Arms:
arm 1: Patients with mild hepatic impaired function (Child-Pugh A) arm 2: Patients with moderate hepatic impaired function (Child-Pugh B) arm 3: Healthy control subjects

Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Nintedanib
Intervention descriptions: intervention 1: Soft gelatine capsule intervention 2: Soft gelatine capsule intervention 3: Soft gelatine capsule

Protocol document: