Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-13; most recent amendment 2026-07-13.
Status change: Enrolling by Invitation → Completed 2025-12-08
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-10-10
Trial Details
NCT Number NCT07133191
Lead Sponsor Viatris Innovation GmbH
Conditions Healthy Volunteers
Enrollment 32 participants
Start Date 2025-10-07
Primary Completion 2025-11-05 (estimated)
Study Completion 2025-11-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-14