The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.
Unnamed facility
Singapore, Singapore
Unnamed facility
Singapore, Singapore
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Taipei, Taiwan
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 2 years
Maximum tolerated dose of BAY1082439
Time frame: Up to 1 year
Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Time to Cmax (tmax) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
Time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the concentration-time curve over the dosing interval (AUC[0-tau])
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Maximum observed concentration (Cmax)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Time of occurrence of Cmax (tmax)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Terminal phase half-life (t1/2)
Time frame: PK parameters following single and repeat-dose administration in cycle 1
Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1
Time frame: Up to 2 years