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临床试验/NCT03430661
NCT03430661已完成1 期

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

Viatris Innovation GmbH1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2018年1月24日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
77
试验地点
1
主要终点
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.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: ACT-246475 (Drug)

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: Clopidogrel (Drug)

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: Placebo (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

干预措施: ACT-246475 (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

干预措施: Clopidogrel (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

干预措施: ACT-246475 (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

干预措施: Clopidogrel (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

干预措施: Placebo (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

干预措施: Placebo (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

干预措施: ACT-246475 (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

干预措施: Prasugrel (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

干预措施: Placebo (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: ACT-246475 (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: Prasugrel (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: Placebo (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: ACT-246475 (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: Prasugrel (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

干预措施: Placebo (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: ACT-246475 (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: Placebo (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

干预措施: Ticagrelor (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: ACT-246475 (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: Placebo (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: Ticagrelor (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: ACT-246475 (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: Placebo (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

干预措施: Ticagrelor (Drug)

结局指标

主要结局

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.

时间窗: From baseline up to 48 hours

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

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.

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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