NCT02191865

Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Nintedanib	Soft gelatine capsule
DRUG	Nintedanib	Soft gelatine capsule
DRUG	Nintedanib	Soft gelatine capsule

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2014-07-16
• Last updated: 2016-02-01
• Results posted: 2016-02-01

Locations

1 site across 1 country: Germany