A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Chinese Adults With Chronic Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selatogrel, Matching placebo.
- Who it may be relevant to
- Registry conditions: Chronic Coronary Syndrome. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Combination product Selatogrel
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. A single dose of 16 mg selatogrel will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. - Combination product Matching placebo
A single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
Primary outcome measures
- Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) [Time frame: Up to 36 hours post-dose]
- Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity) [Time frame: Up to 36 hours post-dose]
- Maximum plasma concentration (Cmax) [Time frame: Up to 36 hours post-dose]
- Time to reach maximum plasma concentration (tmax) [Time frame: Up to 36 hours post-dose]
- Terminal half-life (t1/2) [Time frame: Up to 36 hours post-dose]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
China · 1 center
- Anzhen Hospital — Beijing
Identifiers
NCT: NCT07615868 · ID-076-109