Single and Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3283142 Given as Immediate Release (IR) Tablets in Chinese Healthy Participants in a Randomized, Placebo-controlled, Single-blind, Group-comparison Design
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percentage of participants with treatment emergent adverse event (TEAEs)
研究概览
简要总结
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of the kidneys to work decreases over time. It is often caused by high blood glucose levels. NPDR is another 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.
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase, which helps widen the blood vessels and regulate blood flow inside the body. This may help increase the blood flow in the kidneys and improve their function. It could also help to restore blood flow to the retina.
This study will include healthy participants who will not benefit from taking BAY3283142. However, the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR.
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants.
For this, researchers will collect the number and percentage of participants who have medical problems, which are also known as 'adverse events', after taking BAY3283142 or a placebo. A placebo looks like the study treatment but does not have any medicine in it.
The study doctor will keep track of all adverse events that happen in the study, even if they are not related to the study treatments.
The participants will be randomly divided into 2 treatment groups. They will take either BAY3283142 as an immediate-release tablet, or a placebo tablet, once, by mouth, based on the group assigned to them. An immediate-release tablet quickly dissolves and releases the drug inside the body.
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week. Researchers will check two different dose strengths of BAY3283142 in this study, starting with a low dose first.
Each participant will be in the study for around 7 weeks, which includes:
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participant's health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study, the study doctor and his/her team will:
Test participants' blood and urine samples and check their overall health
Monitor participants' heart health by electrocardiogram (ECG) and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment, access to the treatment after the study is not planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 18 to 45 years of age (both 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 test and 12-lead ECG.
- •Race: Chinese
- •Body mass index (BMI) within the range 18.0 - 27.9 kg/m² (both inclusive) at screening.
- •Body weight of at least 55 kg at screening.
- •Male and female, female only allowed in the 5 mg dose group. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- •Systolic blood pressure below 100 mmHg or above 140 mmHg (after 15 minutes of supine rest) at screening.
- •Diastolic blood pressure below 60 mmHg or above 90 mmHg (after 15 minutes of supine rest) at screening.
- •Heart rate below 50 or above 90 beats per minute (after 15 minutes of supine rest) at screening.
研究组 & 干预措施
Dose step 2
Participants will receive a high dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
干预措施: BAY3283142 (Drug)
Placebo
Participants will receive placebo on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
干预措施: Placebo (Drug)
Dose step 1
Participants will receive a low dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
干预措施: BAY3283142 (Drug)
结局指标
主要结局
Percentage of participants with treatment emergent adverse event (TEAEs)
时间窗: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
Number of participants with treatment emergent adverse event (TEAEs)
时间窗: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
次要结局
- AUC of BAY3283142(0 to 48 hours post-dose after the first dose on Day 1)
- Cmax of BAY3283142(0 to 48 hours post-dose after the first dose on Day 1)
- AUC/D of BAY3283142(0 to 48 hours post-dose after the first dose on Day 1)
- AUCτ,md of BAY3283142(0 to 24 hours post-dose after the last dose on Day 9)
- Cmax,md of BAY3283142(0 to 24 hours post-dose after the last dose on Day 9)
- AUCτ,md/D of BAY3283142(0 to 24 hours post-dose after the last dose on Day 9)
- Cmax/D of BAY3283142(0 to 48 hours post-dose after the first dose on Day 1)
- Cmax,md/D of BAY3283142(0 to 24 hours post-dose after the last dose on Day 9)