Clinical trial

A Multi-center, Open-label, Randomized, Study to Assess the Onset of Platelet Aggregation Inhibition After a Single Subcutaneous Injection of ACT-246475 in Adults With Acute Myocardial Infarction

Name

ID-076A202

Description

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Trial arms

Trial start

2018-07-10

Estimated PCD

2018-11-10

Trial end

2018-11-10

Status

Completed

Phase

Early phase I

Treatment

Selatogrel 8 mg

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 and further diluted with 1 mL sodium chloride (NaCl) 0.9%.

Arms:

Selatogrel 8 mg

Other names:

ACT-246475

Selatogrel 16 mg

Arms:

Selatogrel 16 mg

Other names:

ACT-246475

Size

Primary endpoint

Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation

30 minutes after the administration of the subcutaneous injection

Eligibility criteria

Main Inclusion Criteria: * Informed consent obtained prior to any study-mandated procedure, * Males aged from 18 to 85 and postmenopausal females aged up to 85 years, * Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization, * Subjects presenting a type I AMI including STEMI or NSTEMI. Main Exclusion Criteria: * Cardiogenic shock or severe hemodynamic instability, * Cardiopulmonary resuscitation, * Loading dose of any oral P2Y12 receptor antagonist prior to randomization, * Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization, * Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease). * Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding. * Known clinically important anemia. * Oral anticoagulation therapy within 7 days prior to randomization

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2022-11-17

1 organization

1 product

1 indication

Product

Selatogrel

Indication

Myocardial Infarction

Organization

Idorsia Pharmaceuticals