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NCT Number: NCT07615868

A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anzhen Hospital

Beijing, 100029, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selatogrel

Combination Product

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.

Matching placebo

Combination Product

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 outcomes

  1. 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

    The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles

  2. Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity)

    Time frame: Up to 36 hours post-dose

    The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles

  3. Maximum plasma concentration (Cmax)

    Time frame: Up to 36 hours post-dose

    The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax

  4. Time to reach maximum plasma concentration (tmax)

    Time frame: Up to 36 hours post-dose

    The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax

  5. Terminal half-life (t1/2)

    Time frame: Up to 36 hours post-dose

    The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles

Study contacts

Contact information is provided by the study sponsor or research team.

Viatris Innovation Clinical Trial Information

CONTACT

[email protected]

+1 833 643 8188

Sponsors and collaborators

Lead sponsor

Viatris Innovation GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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