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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...
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Single dose of BAY3283142 IR is an investigational small molecule developed by Bayer AG that was studied as a single oral immediate release tablet. It was evaluated in a Phase 1 trial in participants with reduced kidney function compared with participants with normal kidney function, and it has not been approved for any use.
Single dose of BAY3283142 IR was studied in chronic kidney disease to learn how the treatment moves into, through, and out of the body, how safe it is, and how it affects the body in participants with reduced kidney function compared with participants with normal kidney function. It is investigational and not approved for treating chronic kidney disease.
Bayer AG develops single dose of BAY3283142 IR. Bayer trades on the OTC market under the ticker BAYRY. The compound was studied in a single Phase 1 trial conducted in Germany.
Single dose of BAY3283142 IR is in Phase 1 development. The only listed trial, NCT05515432, is a completed Phase 1 study. The drug is investigational and has not been approved by the FDA or any other regulator for chronic kidney disease or any other indication.
Single dose of BAY3283142 IR was studied in one Phase 1 trial, NCT05515432, titled a study of how BAY3283142 taken as a single oral dose moves into, through, and out of the body, its safety, and its effects in participants with reduced kidney function compared with those with normal kidney function. The trial enrolled 45 participants in Germany and is completed.
Yes. Single dose of BAY3283142 IR and single oral dose of BAY3283142 IR (immediate release) tablet refer to the same investigational Bayer compound given as one oral immediate release dose. The IR designation stands for immediate release, describing the tablet formulation used in the Phase 1 study.