check_circleStudy Completed

Contrast enhancement in magnetic resonance imaging

A study to evaluate the pharmacokinetics (how it moves into, through and out from the body) of a new gadolinium-based contrast agent (GBCA) after injection and how safe it is in participants with normal and impaired renal function

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
24
Trial Dates
October 2021 - July 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1747846
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Alliance for Multispecialty Research, LLC - KnoxvilleKnoxville, 37920, United States
Completed
Clinical Pharmacology of Miami, LLCMiami, 33014, United States

Primary Outcome

  • Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC)
    date_rangeTime Frame:
    Pre-dose until 7 days post-dose
  • Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax)
    date_rangeTime Frame:
    Pre-dose until 7 days post-dose
  • Total body clearance of BAY1747846 normalized by body weight
    date_rangeTime Frame:
    Pre-dose until 7 days post-dose

Secondary Outcome

  • Number of participants with treatment-emergent adverse events
    date_rangeTime Frame:
    After administration of study intervention up to Day 12 (± 2 days)
  • Number of participants with treatment-emergent adverse events categorized by severity
    date_rangeTime Frame:
    After administration of study intervention up to Day 12 (± 2 days)

Trial design

Open-label, single-dose study to evaluate the pharmacokinetics and safety of BAY1747846 in participants with impaired renal function in comparison to matched participants with normal renal function
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3