Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 12:16 AM
Study NCT ID:
NCT02096718
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Afatinib in Subjects With Kidney Dysfunction
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004825-98 | EUDRACT_NUMBER | EudraCT | View |