NCT05491642

A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses

Study in Male / Postmenopausal Female Participants With Mild to Moderate Arterial Hypertension to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 3283142 in a Randomized, Multi-center, Placebo-controlled, Single-blind, Group Comparison Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 30 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly. In people with CKD, the kidneys do not remove wastes and extra fluid from the blood as well as they should. High blood pressure makes it more likely that the CKD gets worse. The study treatment BAY3283142 is under development for treating CKD. It activates 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. The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. As many people with CKD do also suffer from high blood pressure, this study is done in people with mild to moderate high blood pressure to safeguard the use of BAY3283142 in people with CKD in later studies. The main purpose of this study is to learn how safe different single and multiple doses of the study treatment BAY3283142 are compared to placebo in male and female participants (after menopause) with mild to moderate high blood pressure. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the researchers will compare the number of participants who have medical problems after taking BAY3283142 to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once or twice a day. Patients will take one dose for 6 days and will then be switched to a higher dose for additional 6 days. In summary, three different dose combinations consisting of two different doses each will be tested. Participants will be in the study for up to 7 weeks, including 12 treatment days (6 per dose step). They will stay in-house for 17 days starting two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned. During the study, the study team will: * Check vital signs * Take blood and urine samples * Examine the participants' heart health using electrocardiogram (ECG)

Conditions

• Chronic Kidney Disease
• Hypertension

Interventions

Type	Name	Description
DRUG	BAY3283142	Oral administration
DRUG	Placebo to BAY3283142	Oral administration

Timeline

• Start date: 2022-09-08
• Primary completion: 2023-01-03
• Completion: 2023-04-28
• First posted: 2022-08-08
• Last updated: 2023-05-17

Locations

4 sites across 2 countries: Bulgaria, Germany