Safety and PK Study of BIBF 1120 in Japanese Patients With IPF
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ClinicalTrials.gov Identifier: NCT01136174 |
Recruitment Status :
Completed
First Posted : June 3, 2010
Results First Posted : January 6, 2015
Last Update Posted : January 6, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: Placebo Drug: BIBF 1120 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Official Title: | 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. |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: BIBF 1120 50 mg
Low dose for cohort 1
|
Drug: BIBF 1120
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively |
Experimental: BIBF 1120 100 mg
Middle dose for cohort 2
|
Drug: BIBF 1120
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively |
Experimental: BIBF 1120 150 mg
High dose for cohort 3
|
Drug: BIBF 1120
50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively |
Placebo Comparator: Placebo
Placebo for cohort 1,2,3
|
Drug: Placebo
Placebo BID for cohort 1,2,3 |
- Drug-related Adverse Events [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]The number of patients with drug-related adverse events stratified according to pirfenidone use in each group
- AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone [ Time Frame: 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) ]
AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone in the time frame mentioned.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 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
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 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
- Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone [ Time Frame: 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) ]
Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 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
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 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
- AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone [ Time Frame: 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) ]
AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone in the time frame mentioned.
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 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
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 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
- Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone [ Time Frame: 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) ]
Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone
Detailed outcome measure time frame:
In 50 mg and 100 mg dose group:
BIBF 1120:
days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 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
In 150 mg dose group:
BIBF 1120:
days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 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
- AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) [ Time Frame: 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 was calculated as the area under the curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast) in the time frame mentioned.
- Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) [ Time Frame: 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 ]Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast)
- AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) [ Time Frame: 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 ]AUC0-4,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast) in the time frame mentioned.
- Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) [ Time Frame: 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 ]Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast)
- AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) [ Time Frame: 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 ]AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after lunch) in the time frame mentioned.
- Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) [ Time Frame: 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 ]Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg Without BIBF 1120 (after lunch)
- AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) [ Time Frame: 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 ]AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch) in the time frame mentioned.
- Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) [ Time Frame: 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 ]Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch)
- Withdrawal Due to Adverse Event [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]Number of patients prematurely discontinued from trial medication due to adverse event.
- Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - No pirfenidone background
- Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - With pirfenidone background
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: baseline and day 35 ]Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Change From Baseline in Pulse Rate [ Time Frame: baseline and day 35 ]Change from baseline in pulse rate at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco) [ Time Frame: baseline and day 35 ]Change in diffusing capacity for carbon monoxide (DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco) [ Time Frame: baseline and day 35 ]Change in Diffusing Capacity for Carbon Monoxide percent of predicted (%DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: baseline and day 35 ]Change in forced expiratory volume in 1 second (FEV1) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Lung Function Measurement: Forced Vital Capacity (FVC) [ Time Frame: baseline and day 35 ]Change in forced vital capacity (FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.
- Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC) [ Time Frame: baseline and day 35 ]Change in Forced Vital Capacity percent of predicted (%FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
- Forced vital capacity (FVC) 50-90%
- Diffusing capacity for carbon monoxide (DLCO) 30-79%
- For patients on pirfenidone, have been on a steady dose for at least 3 months
Exclusion criteria:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal range (ULN) at screening.
- Bilirubin > 1.5 x ULN at screening.
- Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.
- Continuous oxygen supplementation.
- Active infection at screening or randomisation.
-
Being treated with any of the following concomitant medications.
- Oral corticosteroid medication at unstable dose
- ketoconazole or atazanavir
- Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136174
Japan | |
1199.31.002 Boehringer Ingelheim Investigational Site | |
Bunkyo-ku,Tokyo, Japan | |
1199.31.004 Boehringer Ingelheim Investigational Site | |
Hamamatsu, Shizuoka, Japan | |
1199.31.008 Boehringer Ingelheim Investigational Site | |
Himeji, Hyogo, Japan | |
1199.31.006 Boehringer Ingelheim Investigational Site | |
Nagoya, Aichi, Japan | |
1199.31.007 Boehringer Ingelheim Investigational Site | |
Sakai, Osaka, Japan | |
1199.31.005 Boehringer Ingelheim Investigational Site | |
Seto, Aichi, Japan | |
1199.31.001 Boehringer Ingelheim Investigational Site | |
Shimotsuke,Tochigi, Japan | |
1199.31.003 Boehringer Ingelheim Investigational Site | |
Yokohama, Kanagawa, Japan |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01136174 |
Other Study ID Numbers: |
1199.31 |
First Posted: | June 3, 2010 Key Record Dates |
Results First Posted: | January 6, 2015 |
Last Update Posted: | January 6, 2015 |
Last Verified: | December 2014 |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases |
Nintedanib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |