Randomized Trial to Assess the Pharmacokinetics, the Pharmacodynamics, and the Tolerability of a Single 16 mg Dose of Selatogrel (ACT-246475) in Chinese Adults With Chronic Coronary Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome.
Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body.
Researchers will compare selatogrel to a placebo (a look-alike substance that contains no drug).
Participants will stay at the research clinic for 3 or 4 days (2 or 3 nights), during which time they will receive a single dose of selatogrel or placebo. A telephone call for post-trial safety follow-up will be done 30-40 days after the participant leaves the clinic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic coronary syndrome participants defined by the presence of any of the following conditions:
- •History of coronary artery disease with coronary artery stenosis confirmed by a coronary catheterization (at any time prior to Screening) / computed tomography (CT) angiogram ≥ 50%.
- •Previously documented myocardial infarction occurring more than 3 months prior to Screening.
- •Acetylsalicylic acid as mono antiplatelet background therapy stable for at least 1 month prior to Screening.
- •Minimum weight of 50.0 kg at Screening.
排除标准
- •Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs of coagulopathy).
- •End-stage renal failure requiring dialysis.
- •Treatment with another investigational small-molecule or peptide drug within 3 months or 5 × t1/2 (whichever is longer) or with an investigational antibody treatment within 6 months prior to Screening.
- •History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the metabolism, or excretion of the trial treatment(s) (appendectomy and herniotomy allowed).
- •Concomitant diseases (e.g., advanced liver cirrhosis, mental illness, neurodegenerative disease, terminal malignancy, etc.) or conditions (e.g., inability to communicate well with the investigator in the local language, inability to consent) that, in the opinion of the investigator, may prevent subject from complying with study requirements or may be a confounder for the study interpretation.
- •Conditions associated with atherosclerosis:
- •Acute coronary syndrome, percutaneous coronary intervention, Coronary Artery Bypass Grafting, or any intervention for peripheral artery disease within 3 months prior to randomization.
- •Acute ischemic stroke or transient ischemic attack within 3 months prior to randomization
- •Mitigation of bleeding risks:
- •Active internal bleeding, or medical history of recent (< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis, or any history of intracranial bleeding).
- •Hemoglobin ≤ 10 g/dL at Screening.
- •Loss of at least 250 mL of blood within 3 months prior to Screening.
研究组 & 干预措施
Selatogrel
Study treatment is administered in the morning as a subcutaneous single dose.
干预措施: Selatogrel (Combination Product)
Placebo
Study treatment is administered in the morning as a subcutaneous single dose.
干预措施: Matching placebo (Combination Product)