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NOT YET RECRUITING
NCT07615868
PHASE1

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

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2026-10

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

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.

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.