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Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and impaired renal function. Impaired renal function is a condition where the kidneys do not work as well as they should.
BAY1747846 belongs to the class gadolinium-based contrast agents (GBCAs). The way the body removes GBCAs including BAY1747846 from the blood is through the kidneys. So, when the kidneys are not working normally, it takes longer to remove BAY1747846 out of the body.
The participants in this study will either have normal renal function, or will have mild or moderate impaired renal function. The participants will receive BAY1747846 one time through a needle into a vein.
During the study, the participants will visit the study site about 6 times. The participants will stay at the study site for up to 9 days. Each participant will be in the study for up to 7 months. During the study, the doctors will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild renal impairment | Experimental | Participants with mild renal impairment will receive a single dose of BAY1747846. |
|
| Moderate renal impairment | Experimental | Participants with moderate renal impairment will receive a single dose of BAY1747846. |
|
| Normal renal function | Experimental | Participants with normal renal function will receive a single dose of BAY1747846. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1747846 | Drug | Solution for intravenous (IV) injection, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC) | Pre-dose until 7 days post-dose | |
| Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax) | Pre-dose until 7 days post-dose | |
| Total body clearance of BAY1747846 normalized by body weight | Pre-dose until 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | After administration of study intervention up to Day 12 (± 2 days) | |
| Number of participants with treatment-emergent adverse events categorized by severity | After administration of study intervention up to Day 12 (± 2 days) |
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Inclusion Criteria:
Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent
Renally Impaired Participants and Disease Characteristics
Participants with normal renal function: Normal renal function, as assessed by eGFR ≥90 mL/min/1.73 m^2
Body mass index (BMI) within the range 18 - 40 kg/m^2 (inclusive)
Body weight (bw) ≥ 45 kg
Study participants of reproductive potential must agree to use adequate contraception when sexually active.
Male participants must agree not to donate sperm from the signing of the ICF until the follow-up visit on Day 12 (± 2d).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States | ||
| Alliance for Multispecialty Research, LLC - Knoxville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40215351 | Derived | Fadini T, Sutter G, Klein S, Busemann E, Vendel E, Vis P, Heitmeier S, Frenzel T, Ebert W, Hofmann BM. Pharmacokinetics, Safety, and Dialyzability of Gadoquatrane in Patients With Impaired Renal Function: A Comprehensive Investigation Using Clinical Trial Data, Modeling and Simulation, and In Vitro Data. Invest Radiol. 2025 Nov 1;60(11):779-790. doi: 10.1097/RLI.0000000000001191. | |
| 35703267 |
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Availability of this study's data will later 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.vivli.org 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 member section of the portal.
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| Knoxville |
| Tennessee |
| 37920 |
| United States |
| Derived |
| Lohrke J, Berger M, Frenzel T, Hilger CS, Jost G, Panknin O, Bauser M, Ebert W, Pietsch H. Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. Invest Radiol. 2022 Oct 1;57(10):629-638. doi: 10.1097/RLI.0000000000000889. Epub 2022 Jun 13. |