Try our beta test site

First in Man Trial of BI 113608

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01540825
First received: February 13, 2012
Last updated: November 23, 2016
Last verified: November 2016
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: BI 113608
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 Participants received a single dose of a placebo oral solution of volume matching the respective dose group
BI 113608 0.5mg Participants received a single dose of BI 113608 0.5mg powder for oral solution
BI 113608 1mg Participants received a single dose of BI 113608 1mg powder for oral solution
BI 113608 2mg Participants received a single dose of BI 113608 2mg powder for oral solution
BI 113608 5mg Participants received a single dose of BI 113608 5mg powder for oral solution
BI 113608 10mg Participants received a single dose of BI 113608 10mg powder for oral solution
BI 113608 20mg Participants received a single dose of BI 113608 20mg powder for oral solution
BI 113608 50mg Participants received a single dose of BI 113608 50mg powder for oral solution
BI 113608 100mg Participants received a single dose of BI 113608 100mg powder for oral solution
BI 113608 150mg Participants received a single dose of BI 113608 150mg powder for oral solution
BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution

Participant Flow:   Overall Study
    Placebo   BI 113608 0.5mg   BI 113608 1mg   BI 113608 2mg   BI 113608 5mg   BI 113608 10mg   BI 113608 20mg   BI 113608 50mg   BI 113608 100mg   BI 113608 150mg   BI 113608 200mg
STARTED   20   6   6   6   6   6   6   6   6   6   6 
COMPLETED   20   6   6   6   6   6   6   6   6   6   6 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 which included all randomised subjects who received 1 dose of the study drug.

Reporting Groups
  Description
Placebo Participants received a single dose of a placebo oral solution of volume matching the respective dose group
BI 113608 0.5mg Participants received a single dose of BI 113608 0.5mg powder for oral solution
BI 113608 1mg Participants received a single dose of BI 113608 1mg powder for oral solution
BI 113608 2mg Participants received a single dose of BI 113608 2mg powder for oral solution
BI 113608 5mg Participants received a single dose of BI 113608 5mg powder for oral solution
BI 113608 10mg Participants received a single dose of BI 113608 10mg powder for oral solution
BI 113608 20mg Participants received a single dose of BI 113608 20mg powder for oral solution
BI 113608 50mg Participants received a single dose of BI 113608 50mg powder for oral solution
BI 113608 100mg Participants received a single dose of BI 113608 100mg powder for oral solution
BI 113608 150mg Participants received a single dose of BI 113608 150mg powder for oral solution
BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
Total Total of all reporting groups

Baseline Measures
   Placebo   BI 113608 0.5mg   BI 113608 1mg   BI 113608 2mg   BI 113608 5mg   BI 113608 10mg   BI 113608 20mg   BI 113608 50mg   BI 113608 100mg   BI 113608 150mg   BI 113608 200mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   6   6   6   6   6   6   6   6   6   6   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.0  (10.0)   29.2  (8.1)   34.8  (6.4)   36.8  (12.8)   28.5  (9.5)   41.2  (4.6)   30.5  (9.6)   37.2  (11.8)   39.7  (11.7)   35.3  (11.3)   38.8  (9.2)   35.9  (10.0) 
Gender 
[Units: Participants]
Count of Participants
                       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      20 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      6 100.0%      80 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test   [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]

2.  Primary:   Percentage of Participants With Drug-related Adverse Events   [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]

3.  Primary:   Assessment of Tolerability by the Investigator   [ Time Frame: End of study visit, up to day 10 ]

4.  Secondary:   Cmax   [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

5.  Secondary:   Tmax   [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

6.  Secondary:   AUC0-tz   [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

7.  Secondary:   AUC0-infinity   [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

8.  Secondary:   t1/2   [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01540825     History of Changes
Other Study ID Numbers: 1314.1
2011-005034-19 ( EudraCT Number: EudraCT )
Study First Received: February 13, 2012
Results First Received: November 23, 2016
Last Updated: November 23, 2016