A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

Sponsor
Viatris Innovation GmbH
Study ID
NCT03487445
Phase
PHASE2
Status
Completed

Conditions

  • Acute Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Selatogrel 8 mg — DRUG
    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%.
  • Selatogrel 16 mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 10, 2018
Status verified
Nov 2022
Primary completion
Nov 10, 2018
Completion
Nov 10, 2018

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selatogrel 8 mg
    Selatogrel (ACT-246475) is given as a single subcutaneous dose of 8 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.
  • Experimental: Selatogrel 16 mg
    Selatogrel (ACT-246475) is given as a single subcutaneous dose of 16 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel.

Primary Outcome Measure

Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation [ Time Frame: 30 minutes after the administration of the subcutaneous injection ]

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