Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Single oral dose of BAY3283142 IR (immediate release) tablet
Single dose of BAY3283142 IR · 1 trial · 3 indications
AUC(0-tlast) will be used as main parameters if AUC cannot be reliably determined in all participants
AUC(0-tlast)u will be used as main parameters if AUC cannot be reliably determined in all participants
| Arm | Type | Description |
|---|---|---|
| Mildly impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥60 - <90 | EXPERIMENTAL | Participants with renal impairment |
| Moderately impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥30 - <60 | EXPERIMENTAL | Participants with renal impairment |
| Severely impaired renal funtion: eGFR (mL/min/1.73 m^2) <30 | EXPERIMENTAL | Participants with renal impairment |
| ESRD (end stage renal disease) on dialysis | EXPERIMENTAL | Participants with renal impairment |
| Normal renal function (control group): eGFR (mL/min/1.73 m^2) ≥90 | EXPERIMENTAL | Age-, weight-, and gender-matched participants with normal renal function as control group |
| Name | Type | Description |
|---|---|---|
| Single oral dose of BAY3283142 IR (immediate release) tablet | DRUG | Single oral dose of BAY3283142 in participants with renal impairment compared to an age, gender and weight matched control group in an open-label study design |
Inclusion Criteria: * Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent. * Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration). * Race: White (Note: Clinical D...
Top 20 of 25 competitors