NCT02329184已完成1 期
Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic Cardiomyopathy
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
- 15
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Diagnosed with HCM
- •Normal left ventricular ejection fraction (LVEF)
- •NYHA class I, II or III
排除标准
- •Inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous syndrome (e.g., Noonan's, Fabry's).
- •History of clinically important atrial or ventricular arrhythmias
- •History of positive human immunodeficiency virus (HIV) test and/or seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV)..
研究组 & 干预措施
MYK-461
Experimental
干预措施: MYK-461 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 28 Days
次要结局
- Determination of pharmacokinetics parameters as measured by t1/2(28 Days)
- Determination of pharmacokinetics parameters as measured by Cmax(28 Days)
- Determination of pharmacokinetics parameters as measured by AUC(28 Days)
- Determination of pharmacokinetics parameters as measured by Tmax(28 Days)
研究者
相似试验
已完成
1 期
Single Ascending Dose Study of MYK-461 in Healthy VolunteersHealthyNCT02356289MyoKardia, Inc.48
进行中（未招募）
1 期
A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic MalignanciesNon Hodgkin LymphomaChronic Lymphocytic LeukemiaNCT03913949Ascentage Pharma Group Inc.74
招募中
1 期
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of LymphomaRecurrent or Refractory B-cell Non Hodgkin's LymphomaNCT06503211The First Affiliated Hospital with Nanjing Medical University10
撤回
1 期
3D011-08 Monotherapy in Subjects With Advanced Solid TumorsSolid Tumor, AdultNCT050995363D Medicines (Beijing) Co., Ltd.
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid TumorsAdvanced Solid TumorMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial CarcinomaEsophageal Squamous Cell CarcinomaCervical CancerHepatoCellular CarcinomaSmall-cell Lung CancerMesotheliomaPD-L1 Amplified Tumor (9p24.1)Merkel Cell CarcinomaNasopharyngeal CarcinomaNCT04242199Incyte Corporation182