Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY184… (NCT02894385) | Clinical Trial Compass
CompletedPhase 1
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
Germany29 participantsStarted 2016-09-13
Plain-language summary
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
Who can participate
Age range45 Years – 79 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All subjects
\-- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m\*2 (both inclusive).
* Patients with moderate hepatic impairment (Part 1)
\-- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
* Patients with severe renal impairment (Part 1)
\-- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m\*2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).
* Healthy subjects
\-- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate \>90 mL/min (according to Modified Diet of Renal Disease equation).
* Patients with moderate renal impairment (Part 2)
\-- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL/min/1.73 m\*2 (Stage 3).
* Patients with mild renal impairment (Part 2)
\-- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL/min/1.73 m\*2 (Stage 2).
* Patients with mild hepatic impairment (Part 2)
* Patients with documented liver cirrhosis confirmed by histopathology, e…
What they're measuring
1
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
Timeframe: Pre-dose up to 48 h post dose
2
Maximum drug concentration (Cmax) of darolutamide in plasma