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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01136174
First received: May 31, 2010
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: Placebo
Drug: BIBF 1120
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and intensity of adverse events [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]
  • Withdrawal due to adverse events [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory tests (Hematology, Biochemistry, Urine, Stool). Data will be analysed both quantitatively as well as qualitatively. [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]
  • Lung function measurement: Spirometry: Forced vital capacity (FVC), Forced expiratory volume in 1second (FEV1) [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]
  • Lung function measurement: Diffusing capacity for carbon monoxide (DLCO) [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]
  • Vital signs (systolic and diastolic blood pressure and pulse rate). Data will be assessed with regard to possible changes compared to findings before start of treatment. [ Time Frame: 2 weeks for cohort 1& 2 and 4 weeks for cohort 3 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2010
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136174

Locations
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
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01136174     History of Changes
Other Study ID Numbers: 1199.31
Study First Received: May 31, 2010
Last Updated: August 23, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2013