Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
29
600 mg single dose, administered as 2 x 300 mg tablets on Day 00.
Unnamed facility
Kiel, Schleswig-Holstein, Germany
Unnamed facility
Lübeck, Germany
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide in plasma
Time frame: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Area under the concentration-time curve of darolutamide's major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma
Time frame: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma
Time frame: Pre-dose up to 48 h post dose
Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)
Time frame: From first application of study medication up to 30 days after end of treatment with study medication.
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