Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5 · 1 trial · 1 indication
maximum observed drug concentration in measured matrix after single dose administration
area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
maximum unbound drug concentration in plasma after single dose administration
area under the unbound plasma concentration vs time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
| Arm | Type | Description |
|---|---|---|
| Experimental: Treatment 1 | EXPERIMENTAL | Participants in Groups 1-4 and Group 6 will receive a single dose of BAY2433334 on one occasion. Participants in Group 5 will receive a single dose of BAY2433334 on a dialysis-free day. |
| Experimental: Treatment 2 | EXPERIMENTAL | Participants in Group 5 will receive a single dose of BAY2433334 on a day with dialysis treatment. |
| Name | Type | Description |
|---|---|---|
| BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5 | DRUG | Tablet, oral |
| BAY2433334 on dialysis treatment day | OTHER | Tablet, oral |
Inclusion Criteria: * All participants: ≥18 years, male or female (non-WOCBP only), BMI 18-35 kg/m² (inclusive); no increased risk of bleeding or common causes of bleeding, no liver dysfunction; no CYP3A4 inhibitors/inducers; * Participants with reduced kidney function including those on kidney rep...