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

Part of paid clinical trials in Anaheim, California.

Sponsor
Viatris Innovation GmbH
Study ID
NCT07133191
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Selatogrel — COMBINATION_PRODUCT
    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.
  • Matching placebo — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Aug 2025
Primary completion
Nov 5, 2025
Completion
Nov 6, 2025

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Selatogrel
    Study treatment is administered in the morning as a subcutaneous single dose.
  • Placebo Comparator: Placebo
    Study treatment is administered in the morning as a subcutaneous single dose.

Primary Outcome Measure

Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) [ Time Frame: Up to 36 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CenExel ACT (Anaheim Clinical Trials)AnaheimCalifornia92801-

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By research site
CenExel ACT (Anaheim Clinical Trials)· Anaheim, CA

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