Phase 1
Completed N=32
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Source: ClinicalTrials.gov NCT01580306 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: AUC0-∞ — 76500; 86900; 136000; 129000 ng*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-∞ |
76500; 86900; 136000; 129000 | — |
| PRIMARY Cmax |
3810; 4080; 6680; 4600 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Drug Related Adverse Events |
5; 8; 5; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01580306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.