CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
BAY1747846drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05061979
NCT05061979Phase 1Completed

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

Bayer·interventional·Posted Sep 30, 2021·Updated Nov 21, 2022

In Brief

A Phase 1 clinical trial evaluating BAY1747846 for Contrast Enhancement in Magnetic Resonance Imaging. Completed, enrolled 24 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedSep 30, 2021
Enrollment StartOct 12, 2021
Primary CompletionMar 16, 2022
Study CompletionJul 14, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.8 years ago

Interventions

BAY1747846drug

Solution for intravenous (IV) injection, single dose