account_circleRecruiting

Chronic kidney disease, Arterial hypertension

A study to learn about the safety of BAY3283142 in people with mild to moderate high blood pressure

Trial purpose

In this study, researchers want to learn about the safety of BAY3283142 after a single dose and multiple doses in participants with mild to moderate high blood pressure. The study treatment called BAY3283142 helps to relax blood vessels. It is currently under development for the treatment of chronic kidney disease (CKD). CKD is a condition in which the kidneys’ ability to work gradually decrease over time. During this study, participants will take either different doses of the study drug BAY3283142 as tablets by mouth or a placebo. A placebo looks like the study drug but does not have any medicine in it. At the start of this study, the study doctor will check the medical history and current medications of the participants. They will also perform a complete health check on all the participants. Researchers will collect blood and urine samples from the participants at different time points to assess the safety and effects of BAY3283142. Each treatment scheme will consist of three doses that are given in a consecutive manner. For the first 7 days, participants will receive a lower dose of BAY3283142 in each treatment scheme. The middle and the higher dose of each treatment scheme will be given for 14 days and 7 days respectively. Participants will not know which treatment (placebo or BAY3283142) they will be given, but the study doctor will know which group received which treatment. A participant can be in the study for 10 weeks. This study will be conducted on men or postmenopausal women participants with mild to moderate high blood pressure who may not directly benefit from treatment with BAY3283142. However, information collected in this study will serve as a basis for the development of BAY3283142 for the treatment of people with CKD. Participants may experience pain and discomfort when blood samples are taken.

The researchers will closely monitor and manage any medical problems that the participants may have during the study.

Key Participants Requirements

Sex

All

Age

30 - 72 Years

Trial summary

Enrollment Goal
72
Trial Dates
August 2024 - November 2025
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY3283142
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Clinical Research Services | Clinical Research Services Mannheim - Phase one unitMannheim, 68167, Germany
Recruiting
CRS Clinical Research Services Berlin GmbHBerlin, 13627, Germany

Primary Outcome

  • Number of participants with treatment-emergent adverse events per treatment arm (pooled placebo analysis)
    date_rangeTime Frame:
    up to 7 days after last intake of study intervention

Trial design

Study in participants with mild to moderate arterial hypertension to investigate safety and tolerability of BAY3283142 in a randomized, single-blind, placebo-controlled, multi-center, group comparison design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4