A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Chinese Adults With Chronic Coronary Syndrome

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorViatris Innovation GmbH

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Selatogrel
  • Matching placebo

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators