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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580306
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: BI 201335 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial
Study Start Date : April 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 201335 relevant treatment dose (A)
Capsule for oral administration
 Drug: BI 201335
Relevant treatment dose capsule (A) for oral administration
Experimental: BI 201335 relevant treatment dose (B)
Capsule for oral administration
 Drug: BI 201335
Relevant treatment dose capsule (B) for oral administration


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

    area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.

    In this endpoint, the data of AUC0-∞ show inter-individual variabilities.


  2. 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 ]
    maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.


Secondary Outcome Measures :
  1. Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG [ Time Frame: from drug administration up to 2 weeks ]
    Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

  2. Number of Participants With Drug Related Adverse Events [ Time Frame: drug administration until end-of-study examination (7 to 14 days after drug administration) ]
    number of participants with investigator-defined drug related adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Exclusion criteria:

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580306


Locations
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Germany
1220.58.1 Boehringer Ingelheim Investigational Site
Kiel, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01580306    
Other Study ID Numbers: 1220.58
2011-005442-35 ( EudraCT Number: EudraCT )
First Posted: April 19, 2012    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections