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A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
Sponsor: Viatris Innovation GmbH
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
Conditions
Interventions
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.
Placebo
Matching placebo for subcutaneous administration.
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