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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
1220.58.1 Boehringer Ingelheim Investigational Site
Kiel, Germany
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.
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
Cmax
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
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.
Time frame: from drug administration up to 2 weeks
Number of Participants With Drug Related Adverse Events
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)
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