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: * check the participants' overall health * take blood and urine samples * ask the participants about what medications they are taking and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Solution for intravenous (IV) injection, single dose
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Alliance for Multispecialty Research, LLC - Knoxville
Knoxville, Tennessee, United States
Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC)
Time frame: Pre-dose until 7 days post-dose
Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax)
Time frame: Pre-dose until 7 days post-dose
Total body clearance of BAY1747846 normalized by body weight
Time frame: Pre-dose until 7 days post-dose
Number of participants with treatment-emergent adverse events
Time frame: After administration of study intervention up to Day 12 (± 2 days)
Number of participants with treatment-emergent adverse events categorized by severity
Time frame: After administration of study intervention up to Day 12 (± 2 days)
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