A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure

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

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) and nonproliferative diabetic retinopathy (NPDR). CKD is a condition in which the kidneys' ability to work gradually decrease over time. NPDR is a condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes. 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 each. 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 or NPDR. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease; Arterial Hypertension; Non-proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: BAY3283142; Drug: Placebo to BAY3283142

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GmbH
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Clinical Research Services | Clinical Research Services Mannheim - Phase one unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be 30 to 72 years of age inclusive, at the time of signing the informed consent.
• Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs
• No planned changes to antihypertensive treatment during active treatment phase of the study.
• Estimated glomerular filtration rate ≥45 mL/min/1.73 m2 (CKD-Epi formula) at screening and Study Day -2.
• Men and confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 miU/mL) or women with iatrogenic menopause due to bilateral oophorectomy

Exclusion Criteria:

• Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis)
• Any surgical or medical condition which significantly alters the absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal tract surgery, cholecystectomy, inflammatory bowel disease, chronic diarrhea, currently active gastritis, and pancreatitis
• Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
• PDE inhibitors starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.
• sGC stimulators or activators starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment scheme 1; The Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose.	Drug: BAY3283142; oral administration; Drug: Placebo to BAY3283142; oral administration
Experimental: Treatment scheme 2; Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose.	Drug: BAY3283142; oral administration; Drug: Placebo to BAY3283142; oral administration
Experimental: Treatment scheme 3; Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose.	Drug: BAY3283142; oral administration; Drug: Placebo to BAY3283142; oral administration
Experimental: Treatment scheme 4; Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose.	Drug: BAY3283142; oral administration; Drug: Placebo to BAY3283142; oral administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): August 16, 2024
• Primary Completion (Estimated): July 29, 2025
• Study Completion (Estimated): July 29, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Estimated): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Eye Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Retinopathy
• Other Study ID Numbers: 22723; 2024-512060-58-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No