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.
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.
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).
Parallel
Selatogrel
Combination productSelatogrel 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.
Matching placebo
Combination productA 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.
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
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)
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Maximum plasma concentration (Cmax)
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
Time to reach maximum plasma concentration (tmax)
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
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