A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants

NCT05800444 | Completed Phase 1

• 1 other identifier: 21938
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly. The study treatment BAY3283142 is under development for treating 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. The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure:

• The average highest level of BAY3283142 in the blood (also called Cmax)
• The average total level of BAY3283142 in the blood (also called AUC). Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The study doctors will look at the results from these participants and then decide whether to increase the amount of the study treatment in the next group of participants. Researchers use dose escalation studies to learn about the safety of a specific amount before participants are given a higher amount. Participants will be in the study for up to 7 weeks, including an in-house stay of up to 15 days. One test (screening) visit to the study center is planned before the start of treatment and one follow-up visit is planned after the end of treatment. During the study, the study team will:
• check vital signs
• do physical examinations
• take blood and urine samples
• examine the participants' heart health using electrocardiogram (ECG)

Conditions

Chronic Kidney Disease; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to 7 days after end of treatment with study intervention, an average of 18 days

Secondary Outcomes (4)

• Area under the concentration versus time curve from zero to infinity (AUC) after single (first) dose of BAY3283142 on Day 1

  0 to 48 hours post-dose

• Maximum observed drug concentration (Cmax) after single (first) dose administration of BAY3283142 on Day 1

  0 to 48 hours post-dose

• AUC during any dose interval after (last) multiple doses of BAY3283142 on Day 9 (AUCτ,md)

  0 to 24 hours post-dose

• Maximum observed drug concentration in measured matrix after (last) multiple doses of BAY3283142 on Day 9 (Cmax,md)

  0 to 24 hours post-dose

Study Arms (4)

BAY3283142 (low dose)

EXPERIMENTAL

Participants will receive BAY3283142 as single low dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9.

Drug: BAY3283142

BAY3283142 (medium dose)

EXPERIMENTAL

Participants will receive BAY3283142 as single medium dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9 (optional arm).

Drug: BAY3283142

BAY3283142 (high dose)

EXPERIMENTAL

Participants will receive BAY3283142 as single high dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9.

Drug: BAY3283142

Matching placebo

PLACEBO COMPARATOR

Participants will receive a BAY3283142 matching placebo as single dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9.

Other: Placebo

Interventions

BAY3283142 DRUG

Oral administration as tablet.

BAY3283142 (high dose); BAY3283142 (low dose); BAY3283142 (medium dose)

Placebo OTHER

Oral administration as tablet.

Matching placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 20 to 50 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG.
• Race: Japanese.
• body mass index (BMI) within the range 18.0 and 29.9 kg/m\^2 (inclusive).
• Body weight equal or above 55 kg (inclusive).
• Male: Contraceptive use by men and female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

You may not qualify if:

• Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
• A history of clinically relevant diseases of any organs.
• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
• Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range.
• Known hypersensitivity to the study interventions (active substances or excipients of the preparations, e.g., lactose).
• Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria or significant non-allergic drug reactions.
• Relevant diseases within the last 4 weeks prior to the first intake of study intervention.
• Febrile illness within 2 weeks before the first intake of study intervention.
• Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
• History of gastrointestinal surgery, with the exception of appendectomy (surgery at least 12 months before screening) and inguinal hernia repair (the surgery at least 12 months before screening with the documentation of no intestine necrosis and no intestine segment resection, and participants must be fully recovered and have no signs or symptoms).
• Acute diarrhea or constipation within 14 days before the first intake of study intervention.
• Regular use of medicines.
• Use of any other systemic or topical medicines or substances which oppose the study objectives.
• Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins.
• Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before the first intake of study intervention.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

SOUSEIKAI Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: April 3, 2023
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)