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

NCT07133191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2025-11-05
Completion
2025-11-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133191 on ClinicalTrials.gov