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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01136174
First received: May 31, 2010
Last updated: July 10, 2013
Last verified: July 2013

May 31, 2010
July 10, 2013
May 2010
March 2011   (final data collection date for primary outcome measure)
  • Incidence and intensity of adverse events [ Time Frame: until 4 weeks after completion of trial medication ] [ Designated as safety issue: No ]
  • Withdrawal due to adverse events [ Time Frame: until 4 weeks after completion of trial medication ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01136174 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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), Foced expiratory volume in 1second (FEV), 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 ]
Not Provided
Not Provided
 
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Idiopathic Pulmonary Fibrosis
  • Drug: Placebo
    Placebo BID for cohort 1,2,3
  • Drug: BIBF 1120
    50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
  • Experimental: BIBF 1120 50 mg
    Low dose for cohort 1
    Intervention: Drug: BIBF 1120
  • Experimental: BIBF 1120 100 mg
    Middle dose for cohort 2
    Intervention: Drug: BIBF 1120
  • Experimental: BIBF 1120 150 mg
    High dose for cohort 3
    Intervention: Drug: BIBF 1120
  • Placebo Comparator: Placebo
    Placebo for cohort 1,2,3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
March 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01136174
1199.31
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP