Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01580306
First received: April 12, 2012
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Intervention: Drug: BI 201335

  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
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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
Normal Renal Function

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Mild Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Moderate Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Severe Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2


Participant Flow:   Overall Study
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment  
STARTED     8     8     8     8  
COMPLETED     8     8     8     8  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Normal Renal Function

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2

Mild Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2

Moderate Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2

Severe Renal Impairment

Capsule for oral administration (120 mg Faldaprevir)

subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2

Total Total of all reporting groups

Baseline Measures
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment     Total  
Number of Participants  
[units: participants]
  8     8     8     8     32  
Age  
[units: years]
Mean (Standard Deviation)
  62.3  (2.1)     58.8  (9.3)     67.1  (7.5)     57.6  (9.5)     61.4  (8.2)  
Gender  
[units: participants]
         
Female     2     3     3     3     11  
Male     6     5     5     5     21  



  Outcome Measures
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1.  Primary:   AUC0-∞   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration ]

2.  Primary:   Cmax   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration ]

3.  Secondary:   Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG   [ Time Frame: from drug administration up to 2 weeks ]

4.  Secondary:   Number of Participants With Drug Related Adverse Events   [ Time Frame: drug administration until end-of-study examination (7 to 14 days 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
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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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01580306     History of Changes
Other Study ID Numbers: 1220.58
2011-005442-35 ( EudraCT Number: EudraCT )
Study First Received: April 12, 2012
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices