drugset / Trial / NCT01136174

Safety and PK Study of BIBF 1120 in Japanese Patients With IPF

NCT01136174

Phase 2 Completed 50 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blind

Summary

To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment. To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment. To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with BIBF 1120 treatment.

Timeline

Start
2010-05
Primary completion
2011-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule 50 mg Oral
Subject Nintedanib Small molecule 100 mg Oral
Subject Nintedanib Small molecule 150 mg Oral