At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Afatinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics, Safety and Tolerability of Different Oral Doses of Afatinib, in Subjects With Mild to Moderate Hepatic Impairment Compared to Healthy Subjects - a Phase I, Single-dose, Open-label, Dose-escalation Study in a Matched Group Design
In Brief
A Phase 1 clinical trial evaluating Afatinib for Liver Diseases and Healthy. Completed, enrolled 35 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Diseases, Healthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedFeb 17, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.4 years ago
Interventions
Afatinibdrug
1 tablet, once qd in the morning
Afatinibdrug
1 tablet, once qd in the morning
Afatinibdrug
1 tablet, once qd in the morning