To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Intravenous infusion
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
To measure the plasma concentrations of POL7080
Time frame: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion
Adverse events
Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided.
Time frame: Daily assessment up to 7 days from informed consent
Laboratory abnormalities
The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.
Time frame: Screening, Day -1, Day 2, Day 3, and Day 7
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