Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.
200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.
600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.
Time frame: Pre dose to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration after single dose administration in plasma were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
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Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Area under the concentration versus time curve from time zero to 72 hours (AUC\[0-72h\]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
Time frame: Pre dose up to 72 hours post dose of darolutamide
Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). AEs that occurred on study drug administration were termed as study drug related adverse events.
Time frame: From start of study drug administration up to 30 days after last dose of study medication