account_circleRecruiting

Chronic kidney disease, Non-proliferative diabetic retinopathy, Arterial hypertension

Bayer Identifier:

22723

ClinicalTrials.gov Identifier:

NCT06428825

EudraCT Number:

Not Available

EU CT Number:

2024-512060-58-00
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) 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.

Key Participants Requirements

Sex

All

Age

30 - 72 Years

  • - 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

  • - 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.

Trial summary

Enrollment Goal
72
Trial Dates
August 2024 - July 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