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Selatogrel

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

Ensayo de Viatris Inc en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

32

previstos

Centros

1

Fin del objetivo primario

nov 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2025.

Qué mide

Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) (Up to 36 hours post-dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

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Ficha completa en ClinicalTrials.gov (NCT07133191), actualizada en jul 2026.