Chronic Coronary Syndrome
Conditions
Brief summary
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_PRODUCTSelatogrel
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_PRODUCTMatching 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.
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) | Up to 36 hours post-dose | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles |
| Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity) | Up to 36 hours post-dose | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles |
| Maximum plasma concentration (Cmax) | Up to 36 hours post-dose | The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax |
| Time to reach maximum plasma concentration (tmax) | Up to 36 hours post-dose | The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax |
| Terminal half-life (t1/2) | Up to 36 hours post-dose | The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles |
Countries
China
Contacts
CONTACTViatris Innovation Clinical Trial Information
STUDY_DIRECTORClinical Trials
Viatris Innovation GmbH
Outcome results
None listed