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

Conditions

• Stable Coronary Artery Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Selatogrel — 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) 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 — DRUG
  Matching placebo for subcutaneous administration.
• Selatogrel — 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 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.

Key Dates

Start date

Jan 24, 2018

Status verified

Nov 2022

Primary completion

Aug 18, 2018

Completion

Sep 18, 2018

Study Design

Enrollment

346 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.
• Placebo Comparator: Placebo
  Placebo matching ACT-246475 is supplied in sealed glass vials for reconstitution with water for injection. Placebo will be given as a single subcutaneous dose matching selatogrel to be administered in a volume of 0.8 mL. Administration will 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: From 15 minutes after administration of the subcutaneous injection up to 24 hours ]

Locations (7)

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