NCT03520517已完成1 期
Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis
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
- 22
- 试验地点
- 5
- 主要终点
- Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
Phase 1, open-label study of BHV-0223 in ALS.
详细描述
This is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of BHV-0223 in subjects with ALS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including laboratory supported probable, probable, or definite ALS;
- •Subjects who have never taken riluzole tablets, OR Subjects who previously took riluzole tablets but discontinued at least 1 month prior to the screening visit. Subjects must not have had ALT or AST > 5 x ULN while taking riluzole tablets, or any other clinically significant tolerability issues (e.g., hypersensitivity reactions) in the judgement of the investigator;
- •Subjects determined by the investigator to be medically stable;
- •Subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance.
排除标准
- •Target Disease Exceptions
- •Medical History Exceptions
- •Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
- •Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
- •Subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment;
- •Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
- •Physical and Laboratory Test Findings
- •Positive urine pregnancy test in WOCBP at screening;
- •Subject has evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or other determinations beyond what is consistent with the target population, in the investigator's judgment;
- •Subject has liver function testing abnormalities (ALT, AST , or total bilirubin) that are > 1 x ULN;
- •Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or protocol procedures.
研究组 & 干预措施
BHV-0223
Experimental
riluzole 40 mg sublingual tablet
干预措施: BHV-0223 (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
时间窗: Through Week 8 (Day 57)
Incidence of treatment emergent adverse events (safety and tolerability) as measured through laboratory tests and physical exam findings.
次要结局
- BHV-0223 Concentrations in Blood at Days 1, 29 and 57(Through Week 8 (Day 57))
研究者
研究点 (5)
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