At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
Nintedanib +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 Nintedanib Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With Nintedanib Administration to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)
In Brief
A Phase 1 clinical trial evaluating Nintedanib for Hepatic Insufficiency. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedJul 16, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.0 years ago
Interventions
Nintedanibdrug
Soft gelatine capsule
Nintedanibdrug
Soft gelatine capsule
Nintedanibdrug
Soft gelatine capsule