Conditions: Renal Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function.

The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.

Detailed description:

Arms:
arm 1: Single Dose Afatinib in moderate renal impaired subjects arm 2: Single Dose Afatinib in severe renal impaired subjects arm 3: Single Dose Afatinib in healthy subjects matched by gender, race, age and BMI to moderate and severe renal impaired subjects

Interventions: intervention 1: Afatinib healthy intervention 2: Afatinib severe renally impaired intervention 3: Afatinib moderate renally impaired
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: