Back to resultsPharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 201335
BI 201335
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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
Sites / Locations
- 1220.58.1 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BI 201335 relevant treatment dose (A)
BI 201335 relevant treatment dose (B)
Arm Description
Capsule for oral administration
Capsule for oral administration
Outcomes
Primary Outcome Measures
AUC0-∞
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.
Cmax
maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.
Secondary Outcome Measures
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
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.
Number of Participants With Drug Related Adverse Events
number of participants with investigator-defined drug related adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01580306
Brief Title
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI 201335 relevant treatment dose (A)
Arm Type
Experimental
Arm Description
Capsule for oral administration
Arm Title
BI 201335 relevant treatment dose (B)
Arm Type
Experimental
Arm Description
Capsule for oral administration
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
Relevant treatment dose capsule (A) for oral administration
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
Relevant treatment dose capsule (B) for oral administration
Primary Outcome Measure Information:
Title
AUC0-∞
Description
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.
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
Title
Cmax
Description
maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.
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
Secondary Outcome Measure Information:
Title
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Description
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.
Time Frame
from drug administration up to 2 weeks
Title
Number of Participants With Drug Related Adverse Events
Description
number of participants with investigator-defined drug related adverse events.
Time Frame
drug administration until end-of-study examination (7 to 14 days after drug administration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.58.1 Boehringer Ingelheim Investigational Site
City
Kiel
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
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