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NCT06402721 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT06402721 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 24 participants.
The verdict
NCT06402721, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications. The study treatment, BAY 3283142, is under development to treat CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body. In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142. The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function. For this, the researchers will analyze: * Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function. The study participants will be assigned to one of the four treatment groups based on their liver function: * Group 1: participants with mild reduction in liver function * Group 2: participants with moderate reduction in liver function * Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food. Each participant will be in the study for around 5
Interventions
- DRUG BAY3283142
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-05-17 |
| Est. Completion | 2025-02-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06402721
The ClinicalTrials.gov registry entry for NCT06402721 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BAY3283142 is the first listed.
NCT06402721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06402721 about?
NCT06402721 is a clinical study titled "A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function". Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to th...
What is the current status of trial NCT06402721?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-05-17. Estimated completion is 2025-02-24.
What interventions are being tested in trial NCT06402721?
The interventions under investigation include: BAY3283142 (DRUG).
Who is sponsoring clinical trial NCT06402721?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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