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: December 15, 2014
Last verified: December 2014
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: Placebo
Drug: BIBF 1120

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo oral administration twice a day
BIBF 1120 50 mg BIBF 1120 50 mg oral administration twice a day
BIBF 1120 100 mg BIBF 1120 100 mg oral administration twice a day
BIBF 1120 150 mg BIBF 1120 150 mg oral administration twice a day

Participant Flow:   Overall Study
    Placebo     BIBF 1120 50 mg     BIBF 1120 100 mg     BIBF 1120 150 mg  
STARTED     12     6     8     24  
COMPLETED     12     6     8     20  
NOT COMPLETED     0     0     0     4  
Adverse Event                 0                 0                 0                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set: all patients who received study medication and were documented to have taken at least one dose of investigational treatment

Reporting Groups
  Description
Placebo Placebo oral administration twice a day
BIBF 1120 50 mg BIBF 1120 50 mg oral administration twice a day
BIBF 1120 100 mg BIBF 1120 100 mg oral administration twice a day
BIBF 1120 150 mg BIBF 1120 150 mg oral administration twice a day
Total Total of all reporting groups

Baseline Measures
    Placebo     BIBF 1120 50 mg     BIBF 1120 100 mg     BIBF 1120 150 mg     Total  
Number of Participants  
[units: participants]
  12     6     8     24     50  
Age  
[units: years]
Mean (Standard Deviation)
  64.1  (10.3)     66.7  (2.9)     67.5  (7.4)     64.7  (8.5)     65.2  (8.2)  
Gender  
[units: participants]
         
Female     1     2     4     8     15  
Male     11     4     4     16     35  



  Outcome Measures
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1.  Primary:   Drug-related Adverse Events   [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]

2.  Secondary:   AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone   [ Time Frame: 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) ]

3.  Secondary:   Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone   [ Time Frame: 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) ]

4.  Secondary:   AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone   [ Time Frame: 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) ]

5.  Secondary:   Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone   [ Time Frame: 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) ]

6.  Secondary:   AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)   [ Time Frame: 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 ]

7.  Secondary:   Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)   [ Time Frame: 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 ]

8.  Secondary:   AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)   [ Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose ]

9.  Secondary:   Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)   [ Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose ]

10.  Secondary:   AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)   [ Time Frame: Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose ]

11.  Secondary:   Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)   [ Time Frame: Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose ]

12.  Secondary:   AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)   [ Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose ]

13.  Secondary:   Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)   [ Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose ]

14.  Secondary:   Withdrawal Due to Adverse Event   [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]

15.  Secondary:   Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background   [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]

16.  Secondary:   Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background   [ Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days ]

17.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: baseline and day 35 ]

18.  Secondary:   Change From Baseline in Pulse Rate   [ Time Frame: baseline and day 35 ]

19.  Secondary:   Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)   [ Time Frame: baseline and day 35 ]

20.  Secondary:   Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)   [ Time Frame: baseline and day 35 ]

21.  Secondary:   Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: baseline and day 35 ]

22.  Secondary:   Lung Function Measurement: Forced Vital Capacity (FVC)   [ Time Frame: baseline and day 35 ]

23.  Secondary:   Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)   [ Time Frame: baseline and day 35 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Results First Received: November 14, 2014
Last Updated: December 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency