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NCT05061979 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Contrast Enhancement in Magnetic Resonance Imaging, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05061979: Completed Phase 1 study of Contrast Enhancement in Magnetic Resonance Imaging, sponsored by Bayer.
NCT05061979 is a Phase 1 study of Contrast Enhancement in Magnetic Resonance Imaging that has completed, run by Bayer. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061979, a Phase 1 study of Contrast Enhancement in Magnetic Resonance Imaging, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG BAY1747846
Study Locations (2)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
Tennessee
- Alliance for Multispecialty Research, LLC - Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2022-07-14 |
| Phase | Phase 1 |
What the finished NCT05061979 record still lists
NCT05061979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Contrast Enhancement in Magnetic Resonance Imaging appearing as the primary indexed condition, and to 1 intervention - of which BAY1747846 is the first listed.
NCT05061979 reports a single indexed study location in Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05061979 about?
NCT05061979 is a clinical study titled "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". 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...
What is the current status of trial NCT05061979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-10-12. Estimated completion is 2022-07-14.
What conditions does trial NCT05061979 study?
This clinical trial studies the following conditions: Contrast Enhancement in Magnetic Resonance Imaging.
What interventions are being tested in trial NCT05061979?
The interventions under investigation include: BAY1747846 (DRUG).
Who is sponsoring clinical trial NCT05061979?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05061979 being conducted?
This trial has 2 study locations across Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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