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

NCT01136174 | Completed Phase 2 Results

• 1 other identifier: 1199.31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Drug-related Adverse Events

  The number of patients with drug-related adverse events stratified according to pirfenidone use in each group

  after the first drug intake until 28 days from the last treatment administration, up to 60 days

Secondary Outcomes (22)

• 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)

• 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)

• 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)

• 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

Study Arms (4)

BIBF 1120 50 mg

EXPERIMENTAL

Low dose for cohort 1

Drug: BIBF 1120

BIBF 1120 100 mg

EXPERIMENTAL

Middle dose for cohort 2

Drug: BIBF 1120

BIBF 1120 150 mg

EXPERIMENTAL

High dose for cohort 3

Drug: BIBF 1120

Placebo

PLACEBO COMPARATOR

Placebo for cohort 1,2,3

Drug: Placebo

Interventions

Placebo DRUG

Placebo BID for cohort 1,2,3

Placebo

BIBF 1120 DRUG

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

BIBF 1120 50 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

1199.31.002 Boehringer Ingelheim Investigational Site

Bunkyo-ku,Tokyo, Japan

Location

1199.31.004 Boehringer Ingelheim Investigational Site

Hamamatsu, Shizuoka, Japan

Location

1199.31.008 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

1199.31.006 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1199.31.007 Boehringer Ingelheim Investigational Site

Sakai, Osaka, Japan

Location

1199.31.005 Boehringer Ingelheim Investigational Site

Seto, Aichi, Japan

Location

1199.31.001 Boehringer Ingelheim Investigational Site

Shimotsuke,Tochigi, Japan

Location

1199.31.003 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

Related Publications (1)

• Ogura T, Taniguchi H, Azuma A, Inoue Y, Kondoh Y, Hasegawa Y, Bando M, Abe S, Mochizuki Y, Chida K, Kluglich M, Fujimoto T, Okazaki K, Tadayasu Y, Sakamoto W, Sugiyama Y. Safety and pharmacokinetics of nintedanib and pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1382-92. doi: 10.1183/09031936.00198013. Epub 2014 Dec 10.

  PMID: 25504994 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 3, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Last Updated: January 6, 2015
• Results First Posted: January 6, 2015

Record last verified: 2014-12

Locations

JP (8)