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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000630-19 | EudraCT Number |
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BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Experimental |
| |
| Participants with mild renal impairment | Experimental |
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| Participants with moderate renal impairment | Experimental |
| |
| Participants with severe renal impairment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY2327949 | Drug | A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of BAY2327949 | Cmax: Maximum observed drug concentration in measured matrix after single dose administration | From pre-dose until follow-up (10-12 days after dosing). |
| AUC of BAY2327949 | AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) >20% of AUC | From pre-dose until follow-up (10-12 days after dosing). |
| Cmax,u of BAY2327949 | Cmax,u: Cmax based on the unbound plasma concentrations of the study drug | From pre-dose until follow-up (10-12 days after dosing). |
| AUCu of BAY2327949 | AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC | From pre-dose until follow-up (10-12 days after dosing). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and nature of treatment-emergent adverse events | Approximate 14 days (from starting treatment to end of follow-up) | |
| Urinary volume | From Day -1 until Day 4 (72h after dosing) | |
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Inclusion Criteria:
Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.
Exclusion Criteria:
Clinically relevant findings in the physical examination affecting the objectives of the study.
Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:
Regular daily consumption of more than 10 cigarettes.
Acute renal failure.
Active nephritis.
Impairment of any other major organ system other than the kidney.
Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APEX GmbH | München | Bavaria | 81241 | Germany | ||
| CRS Clinical-Research-Services Kiel GmbH |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Fluid balance |
| From Day -1 until Day 4 (72h after dosing) |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |