NCT02096718

Afatinib in Subjects With Kidney Dysfunction

Pharmacokinetics, Safety and Tolerability After Single Dose Administration of Afatinib in Moderate and Severe Renal Impairment in Comparison to Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Afatinib healthy
DRUG	Afatinib severe renally impaired
DRUG	Afatinib moderate renally impaired

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-03-26
• Last updated: 2016-01-14
• Results posted: 2016-01-14

Locations

1 site across 1 country: Germany