Single-center, Double-blind Trial to Assess the Pharmacokinetics, the Pharmacodynamics, and the Tolerability of a Single 16 mg Dose of Selatogrel (ACT-246475) in Healthy Japanese and Caucasian Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
研究概览
简要总结
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of selatogrel following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study: 16 Japanese participants in one group and 16 Caucasian participants in the other group.
The duration of participation in this study is approximately 70 days from screening to the end of follow-up. A screening visit is required within 28 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 3 or 4 days (2 or 3 nights), an end-of-trial (EOT) examination at least 36 hours after study drug administration, and a post-trial safety follow-up telephone call or site visit 30-40 days after the EOT examination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Signed and dated informed consent form in a language understandable to the participants prior to any trial-mandated procedure.
- •Participant must be of either Caucasian (with European, North African, Middle Eastern origins) or Japanese ethnicity.
- •Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening.
- •Systolic blood pressure 90-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at Screening.
- •12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at Screening.
- •Clinical chemistry test results not deviating from the normal range to a clinically relevant extent at Screening.
- •Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on admission.
- •Negative results from urine drug screen and alcohol breath test at Screening and on admission.
- •Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the requirements of the trial.
- •For participants of childbearing potential: Negative results from serum pregnancy test at Screening and urine pregnancy test on admission. They must consistently and correctly use (from Screening, during the entire trial, and for at least 30 days after trial intervention injection) an acceptable method of contraception, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before trial intervention administration.
排除标准
- •Previous exposure to selatogrel.
- •Pregnant or lactating participant.
- •Known hypersensitivity to P2Y12 receptor antagonists or to excipients used in any of the formulations.
- •Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, transient ischemic attack, reasonable suspicion of vascular malformations, peptic ulcers.
- •Platelet count < 120 × 109 L-1 at Screening or on admission.
- •Any known platelet disorder (e.g., Glanzmann thrombo-asthenia, 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 trial intervention administration.
- •Treatment with another investigational small-molecule drug within 3 months or 5 × half-life (t1/2, whichever is longer) or with an investigational antibody treatment within 6 months prior to Screening, or participation in more than 4 investigational drug trials within 1 year prior to Screening.
- •Excessive caffeine consumption from trial drug administration to EOT, defined as ≥ 800 mg per day at Screening.
- •Nicotine use within 3 months prior Screening and inability to refrain from nicotine intake from Screening until EOT.
- •History or clinical evidence of alcoholism or drug abuse within 3 years prior to Screening.
- •Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) with the exception of contraceptives for participants of childbearing potential within 2 weeks or 5 × t1/2 (whichever is longer) prior to study drug administration.
- •History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed).
- •History of asthma.
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •Legal incapacity or limited legal capacity or vulnerability (e.g., kept in detention) at Screening.
- •Known hypersensitivity or allergy to natural rubber latex.
- •Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the trial.
- •Participant is the investigator or any delegate, research assistant, pharmacist, trial coordinator, other staff from trial site or the sponsor directly involved in the conduct of the trial or their relatives.
研究组 & 干预措施
Placebo
Study treatment is administered in the morning as a subcutaneous single dose.
干预措施: Matching placebo (Combination Product)
Selatogrel
Study treatment is administered in the morning as a subcutaneous single dose.
干预措施: Selatogrel (Combination Product)
结局指标
主要结局
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
时间窗: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity)
时间窗: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Maximum plasma concentration (Cmax)
时间窗: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
Time to reach maximum plasma concentration (tmax)
时间窗: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
Terminal half-life (t1/2)
时间窗: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
次要结局
未报告次要终点