Conditions: Idiopathic Pulmonary Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Low dose for cohort 1 arm 2: Middle dose for cohort 2 arm 3: High dose for cohort 3 arm 4: Placebo for cohort 1,2,3

Interventions: intervention 1: Placebo intervention 2: BIBF 1120 intervention 3: BIBF 1120 intervention 4: BIBF 1120
Intervention descriptions: intervention 1: Placebo BID for cohort 1,2,3 intervention 2: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 3: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 4: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Protocol document: