Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy subjects.
详细描述
This study is a two-part study. Part A is double-blind, placebo-controlled, and will examine the safety and PK profiles of multiple doses of LT3001 drug product in healthy subjects. Part B is open-label and will assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban or dabigatran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32
- •Subject is a healthy volunteer.
- •Subject's PT, aPTT, and TT are within the normal laboratory range.
- •Subject is a nonsmoker
排除标准
- •Subject has a current or recent history of regular alcohol consumption.
- •Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran.
- •Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19*2/*2, *2/*3, or *3/*3 genotype)
- •Subject has a presence or history of coagulation abnormality.
- •Subjects need to receive a surgery or clinical procedures associated with high bleeding risk.
- •Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding.
- •Subject has a history of peptic ulcer or gastrointestinal bleeding.
研究组 & 干预措施
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
干预措施: Apixaban (Drug)
Part A - LT3001 Drug Product
Multiple doses of LT3001 administered by intravenous infusion
干预措施: LT3001 drug product (Drug)
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
干预措施: Placebo (Drug)
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
干预措施: LT3001 drug product (Drug)
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
干预措施: Aspirin (Drug)
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
干预措施: LT3001 drug product (Drug)
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
干预措施: Clopidogrel (Drug)
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
干预措施: LT3001 drug product (Drug)
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
干预措施: LT3001 drug product (Drug)
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
干预措施: Dabigatran (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
To evaluate the safety and tolerability of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran, as determined by the number and severity of adverse events collected from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
次要结局
- Change From Baseline in Activated Partial Thromboplastin Time (APTT)(16 days)
- Number of Participants With Prolongation in Platelet Function Test(16 days)
- Plasma PK Parameters of LT3001 - Cmax(Predose and post-dose time points up to 10 days after dosing)
- Plasma PK Parameters of LT3001 - Tmax(10 days)
- Plasma PK Parameters of LT3001 - AUC(10 days)
- Plasma PK Parameters of Aspirin - Cmax(8 days)
- Plasma PK Parameters of Aspirin - Tmax(8 days)
- Plasma PK Parameters of Aspirin - AUC(8 days)
- Plasma PK Parameters of Clopidogrel - Cmax(10 days)
- Plasma PK Parameters of Clopidogrel - Tmax(10 days)
- Plasma PK Parameters of Clopidogrel - AUC(10 days)
- Plasma PK Parameters of Apixaban - Cmax(8 days)
- Plasma PK Parameters of Apixaban - Tmax(8 days)
- Plasma PK Parameters of Apixaban - AUC(8 days)
- Plasma PK Parameters of Dabigatran - Cmax(8 days)
- Plasma PK Parameters of Dabigatran - Tmax(8 days)
- Plasma PK Parameters of Dabigatran - AUC(8 days)