Phase 2
Completed N=50
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF
Source: ClinicalTrials.gov NCT01136174 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Jan 2015
Primary outcomePrimary: Drug-related Adverse Events — 1; 0; 0; 7 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug-related Adverse Events |
1; 0; 0; 7; 1; 0 | — |
| SECONDARY AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone |
33.7; 115; 218 | — |
| SECONDARY Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone |
9.09; 20.0; 39.7 | — |
| SECONDARY AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone |
67.9; 86.0; 149 | — |
| SECONDARY Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone |
10.9; 13.8; 23.5 | — |
| SECONDARY AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) |
28900; 34400; 45800; 32500 | — |
| SECONDARY Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) |
11300; 11900; 14600; 11200 | — |
| SECONDARY AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) |
28800; 34300; 35000; 35900 | — |
| SECONDARY Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) |
12000; 12800; 15300; 12600 | — |
| SECONDARY AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) |
56600; 72800; 84100; 60900 | — |
| SECONDARY Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) |
13500; 14600; 15100; 12900 | — |
| SECONDARY AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) |
47000; 71000; 71500; 63600 | — |
| SECONDARY Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) |
10700; 12000; 12100; 12500 | — |
| SECONDARY Withdrawal Due to Adverse Event |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
0.5; -0.8; 1.3; 2.5 | — |
| SECONDARY Change From Baseline in Pulse Rate |
-2.5; 1.9 | — |
| SECONDARY Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco) |
-1.131; -0.707 | — |
| SECONDARY Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco) |
-4.660; -1.193 | — |
| SECONDARY Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1) |
-0.021; 0.036 | — |
| SECONDARY Lung Function Measurement: Forced Vital Capacity (FVC) |
-0.081; 0.050 | — |
| SECONDARY Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC) |
-2.311; 1.432 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01136174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.