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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Coronary Syndrome
• Intervention / Treatment: Combination product: Selatogrel; Combination product: Matching placebo

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selatogrel; Study treatment is administered in the morning as a subcutaneous single dose.	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.
Placebo Comparator: Placebo; Study treatment is administered in the morning as a subcutaneous single dose.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 36 hours post-dose
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	Up to 36 hours post-dose
Maximum plasma concentration (Cmax)	The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax	Up to 36 hours post-dose
Time to reach maximum plasma concentration (tmax)	The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax	Up to 36 hours post-dose
Terminal half-life (t1/2)	The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles	Up to 36 hours post-dose

Collaborators and Investigators

• Sponsor: Viatris Innovation GmbH
• Investigators: Study Director: Clinical Trials, Viatris Innovation GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: selatogrel
• Other Study ID Numbers: ID-076-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes