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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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BIBF 1120 50 mg

Low dose for cohort 1

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

BIBF 1120 100 mg

Middle dose for cohort 2

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

BIBF 1120 150 mg

High dose for cohort 3

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Placebo

Placebo for cohort 1,2,3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID for cohort 1,2,3

Interventions

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Placebo

Placebo BID for cohort 1,2,3

Intervention Type DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Intervention Type DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Intervention Type DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No