NCT07133191

A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Japanese and Caucasian Healthy Participants

Single-center, Double-blind Trial to Assess the Pharmacokinetics, the Pharmacodynamics, and the Tolerability of a Single 16 mg Dose of Selatogrel (ACT-246475) in Healthy Japanese and Caucasian Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of selatogrel following a single dose in healthy Japanese and Caucasian participants. 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. There will be 2 groups in the study: 16 Japanese participants in one group and 16 Caucasian participants in the other group. The duration of participation in this study is approximately 70 days from screening to the end of follow-up. A screening visit is required within 28 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 3 or 4 days (2 or 3 nights), an end-of-trial (EOT) examination at least 36 hours after study drug administration, and a post-trial safety follow-up telephone call or site visit 30-40 days after the EOT examination.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-07
• Primary completion: 2025-11-05
• Completion: 2025-11-06
• First posted: 2025-08-20
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study