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Safety Tolerability and Pharmacokinetic of BI 411034

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01581684
First received: April 19, 2012
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: March 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: BI 411034
Drug: Placebo

  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 EM A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
2mg EM Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
8mg EM Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
20mg EM Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
40mg EM Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
80mg EM Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
150mg EM Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
250mg EM Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
Placebo PM A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
20/60mg PM Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers

Participant Flow:   Overall Study
    Placebo EM     2mg EM     8mg EM     20mg EM     40mg EM     80mg EM     150mg EM     250mg EM     Placebo PM     20/60mg PM  
STARTED     14     6     6     6     6     6     6     6     1     5  
COMPLETED     14     6     6     6     6     6     6     6     0     5  
NOT COMPLETED     0     0     0     0     0     0     0     0     1     0  
Other reason not defined                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Placebo EM A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
2mg EM Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
8mg EM Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
20mg EM Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
40mg EM Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
80mg EM Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
150mg EM Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
250mg EM Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
Placebo PM A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
20/60mg PM Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
Total Total of all reporting groups

Baseline Measures
    Placebo EM     2mg EM     8mg EM     20mg EM     40mg EM     80mg EM     150mg EM     250mg EM     Placebo PM     20/60mg PM     Total  
Number of Participants  
[units: participants]
  14     6     6     6     6     6     6     6     1     5     62  
Age  
[units: years]
Mean ± Standard Deviation
  38.4  ± 6.3     35.5  ± 9.9     39.8  ± 4.3     38.8  ± 8.7     38.3  ± 8.2     39.5  ± 3.1     32.7  ± 5.4     43.8  ± 6.7     31.0  ± NA [1]   42.4  ± 8.6     38.6  ± 7.1  
Gender  
[units: participants]
                     
Female     0     0     0     0     0     0     0     0     0     0     0  
Male     14     6     6     6     6     6     6     6     1     5     62  
[1] Measure of dispersion not possible to calculated for one participant



  Outcome Measures
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1.  Primary:   Number of Participants With Drug Related AEs   [ Time Frame: From drug administration until end of trial examination, up to 13 days ]

2.  Primary:   Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests   [ Time Frame: From drug administration until end of trial examination, up to 13 days ]

3.  Secondary:   Maximum Measured Concentration (Cmax )   [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]

4.  Secondary:   Time to Maximum Measured Concentration (Tmax)   [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]

5.  Secondary:   Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)   [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]

6.  Secondary:   Amount of Analyte Eliminated in Urine From 0 to 4 (Ae0-4)   [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01581684     History of Changes
Other Study ID Numbers: 1308.1, 2011-004840-23
Study First Received: April 19, 2012
Results First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices