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COMPLETED
NCT03384966
PHASE2

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

Summary

The goal of this study is to find out if a drug called selatogrel (ACT-246475) can prevent platelets from binding together when administered by an injection under the skin in the thigh or in the belly. Another goal is to know how fast and for how long selatogrel (ACT-246475) works and if there is a difference if the drug is injected in the thigh or in the belly. This study will also help to find out more about the safety of this new drug.

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

346

Start Date

2018-01-24

Completion Date

2018-09-18

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

Selatogrel

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.

DRUG

Placebo

Matching placebo for subcutaneous administration.

DRUG

Selatogrel

Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.

Locations (20)

University of Florida (UF) Jacksonville

Jacksonville, Florida, United States

Florida Hospital Tampa - Pepin Heart Institute

Tampa, Florida, United States

NorthShore University

Chicago, Illinois, United States

Indiana University School of Medicine - Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Inova Cardiology

Lutherville, Maryland, United States

Mount Sinai Hospital (New York)

New York, New York, United States

Inova Center for Thrombosis Research and Translational Medicine

Falls Church, Virginia, United States

Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Universitats-Herzzentrum

Bad Krozingen, Germany

University Medical Center Groningen

Groningen, Netherlands

Maastricht UMC

Maastricht, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

National Heart Centre Singapore

Singapore, Singapore

Sahlgrenska University Hospital

Gothenburg, Sweden

Uppsala University Hospital

Uppsala, Sweden

Freeman Hospital - Cardiothoracic Department

Newcastle upon Tyne, United Kingdom

Sheffield Teaching Hospitals

Sheffield, United Kingdom

East & North Hertfordshire NHS Trust - Lister Hospital

Stevenage, United Kingdom