Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
30
5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.
600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.
CRS Clinical Research Services Berlin GmbH
Berlin, State of Berlin, Germany
Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24))
Time frame: Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
Maximum drug concentration (Cmax) in plasma of Rosuvastatin
Time frame: Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
Number of subjects with study drug-related treatment-emergent Adverse Events
Time frame: Up to 30 days
Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration
Time frame: Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration, period 2 day 1
Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration
Time frame: Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h after BAY1841788 administration, period 2 day 7
Maximum drug concentration (Cmax) in plasma of BAY1841788
Time frame: Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration
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