A Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.

简要总结

主要结局

次要结局

• AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone(pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg))
• Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone(pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg))
• Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)(Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose)
• AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone(pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg))
• AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)(Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose)
• Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone(pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg))
• Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)(Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose)
• AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)(Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose)
• Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)(baseline and day 35)
• Lung Function Measurement: Forced Vital Capacity (FVC)(baseline and day 35)
• Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)(baseline and day 35)
• Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)(Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose)
• AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)(Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose)
• Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background(after the first drug intake until 28 days from the last treatment administration, up to 60 days)
• Change From Baseline in Pulse Rate(baseline and day 35)
• Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)(baseline and day 35)
• AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)(Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose)
• Withdrawal Due to Adverse Event(after the first drug intake until 28 days from the last treatment administration, up to 60 days)
• Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background(after the first drug intake until 28 days from the last treatment administration, up to 60 days)
• Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(baseline and day 35)
• Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)(baseline and day 35)
• Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)(Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose)