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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: BIBF 1120; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136174

1199.31

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
2. Forced vital capacity (FVC) 50-90%
3. Diffusing capacity for carbon monoxide (DLCO) 30-79%
4. For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria

1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal range (ULN) at screening.

2. Bilirubin > 1.5 x ULN at screening.

3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.

4. Continuous oxygen supplementation.

5. Active infection at screening or randomisation.

6. Being treated with any of the following concomitant medications.

   • Oral corticosteroid medication at unstable dose
   • ketoconazole or atazanavir

7. 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

Trial design

50 participants in 4 patient groups, including a placebo group

BIBF 1120 50 mg

Experimental group

Description:

Low dose for cohort 1

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

BIBF 1120 100 mg

Experimental group

Description:

Middle dose for cohort 2

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

BIBF 1120 150 mg

Experimental group

Description:

High dose for cohort 3

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

Placebo

Placebo Comparator group

Description:

Placebo for cohort 1,2,3

Treatment:

Drug: Placebo