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Completed

NCT Number: NCT03430661

A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects

The primary objective of this study is to assess the pharmacodynamic (PD) effects of clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.) dose of ACT-246475 in healthy male and female subjects

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial Inc

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Signed informed consent
  • Healthy male and female subjects aged between 18 and 65 years (inclusive) at screening
  • Body mass index of 18.0 to 31.0 kg/m2 (inclusive) at Screening
  • Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls from screening up to at least 30 days after last study treatment administration
  • Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 beats per minute (bpm) (inclusive) at screening
  • Healthy on the basis of physical examination, cardiovascular assessments, and laboratory tests
  • Maximum (at peak) platelet aggregation ≥ 40% (light transmission aggregometry [LTA]) upon 20 μM adenosine diphosphate (ADP) activation at screening
  • Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/adrenaline and collagen/ADP below the upper limit of normal range at screening

Main Exclusion Criteria:

  • Pregnant or lactating women
  • Known hypersensitivity to ACT-246475, clopidogrel, prasugrel, ticagrelor, any of their excipients, or drugs of the same class
  • Any contraindication to clopidogrel, prasugrel, or ticagrelor treatment
  • Known hypersensitivity or allergy to natural rubber latex
  • Platelet count < 120 × 109 L-1 at Screening and Day -1
  • Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect)
  • Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to study treatment administration
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Treatment and study plan

ACT-246475

Drug

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

clopidogrel

Drug

Tablet for oral administration (300 or 600 mg)

Prasugrel

Drug

Tablet for oral administration (60 mg)

Placebo

Drug

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Ticagrelor

Drug

Tablet for oral administration (180 mg)

Primary outcomes

  1. Time-matched comparisons of IPA% (MPA) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2, treatments are defined below) following administration of ACT-246475 and its matching placebo.

    Time frame: From baseline up to 48 hours

    • IPA%[MPA] will be calculated as mean change in percentage from baseline for each time point.

  2. Time-matched comparisons of IPA %(PRU) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2) following administration of ACT-246475 and its matching placebo.

    Time frame: From baseline up to 48 hours

    • IPA%[PRU] will be calculated as mean change in percentage from baseline for each time point.

    Treatment A1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of clopidogrel (600 mg).

    Treatment A2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of clopidogrel (300 mg).

    Treatment B1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of prasugrel (60 mg).

    Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of prasugrel (60 mg).

    Treatment C1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of ticagrelor (180 mg).

    Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of ticagrelor (180 mg).

Sponsors and collaborators

Lead sponsor

Viatris Innovation GmbH

Industry

Registry information

Official study title

Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, Prasugrel, or Ticagrelor When Administered After a Single Subcutaneous Dose of the P2Y12 Antagonist ACT-246475 in Healthy Male and Female Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2018
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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