Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01298063
First received: February 15, 2011
Last updated: December 5, 2013
Last verified: August 2013
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Liver Diseases
Healthy
Intervention: Drug: Afatinib

  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
50 mg Afatinib Group A Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
30 mg Afatinib Group B1 Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group B2 Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group C Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group D Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).

Participant Flow:   Overall Study
    50 mg Afatinib Group A     30 mg Afatinib Group B1     50 mg Afatinib Group B2     50 mg Afatinib Group C     50 mg Afatinib Group D  
STARTED     8     3     8     8     8  
COMPLETED     8     3     8     8     8  
NOT COMPLETED     0     0     0     0     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.
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Reporting Groups
  Description
50 mg Afatinib Group A Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
30 mg Afatinib Group B1 Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group B2 Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group C Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
50 mg Afatinib Group D Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
Total Total of all reporting groups

Baseline Measures
    50 mg Afatinib Group A     30 mg Afatinib Group B1     50 mg Afatinib Group B2     50 mg Afatinib Group C     50 mg Afatinib Group D     Total  
Number of Participants  
[units: participants]
  8     3     8     8     8     35  
Age  
[units: years]
Mean ± Standard Deviation
  53.9  ± 9.0     64.3  ± 6.1     54.8  ± 9.0     55.9  ± 12.6     53.1  ± 7.9     55.3  ± 9.5  
Gender  
[units: Number¬†of¬†participants]
           
Female     2     0     3     2     3     10  
Male     6     3     5     6     5     25  



  Outcome Measures
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1.  Primary:   Area Under Curve From 0 to Infinity (AUC0-infinity)   [ Time Frame: 30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing ]

2.  Primary:   Maximum Concentration (Cmax)   [ Time Frame: 30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing ]

3.  Secondary:   Area Under Curve From 0 to tz (AUC0-tz)   [ Time Frame: 30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing ]

4.  Secondary:   Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability   [ Time Frame: First administration of trial medication until 28 days after last administration of trial medication ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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: NCT01298063     History of Changes
Other Study ID Numbers: 1200.86, 2010-021140-18
Study First Received: February 15, 2011
Results First Received: August 8, 2013
Last Updated: December 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration