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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: BI 201335
* Drug: BI 201335


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 201335 relevant treatment dose (A)<br>Capsule for oral administration | Drug: BI 201335<br>* Relevant treatment dose capsule (A) for oral administration<br>|
| Experimental: BI 201335 relevant treatment dose (B)<br>Capsule for oral administration | Drug: BI 201335<br>* Relevant treatment dose capsule (B) for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | drug administration until end-of-study examination (7 to 14 days after drug administration) |