NCT05181085已完成1 期
A Phase 1, First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST 6179 in Healthy Subjects
NorthSea Therapeutics B.V.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants With AEs and SAEs Following Administration of NST 6179
研究概览
简要总结
A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Males or females, of any race, between 18 and 65 years of age, inclusive.
- •Body mass index between 18.0 and 32.0 kg/m^2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and/or check in as assessed by the investigator (or designee).
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions
- •Exclusion Criteria (additional criteria available):
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- •Any of the following:
- •QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 ms confirmed by repeat measurement.
- •QRS duration > 110 ms confirmed by repeat measurement.
- •PR interval > 220 ms confirmed by repeat measurement.
- •findings which would make QTc measurements difficult or QTc data uninterpretable.
- •history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- •Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
- •Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only).
- •History of alcoholism or drug/chemical abuse within 2 years
排除标准
- 未提供
研究组 & 干预措施
NST 6179
Active Comparator
double blind, single ascending and multiple ascending dose, sequential group design
干预措施: NST 6179 (Drug)
Placebo
Placebo Comparator
matched placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With AEs and SAEs Following Administration of NST 6179
时间窗: From screening to 14 days post final dose, up to 4 weeks.
Assessment of number of participants with AEs and SAEs to determine safety profile
次要结局
- Peak Plasma Concentration (Cmax) of NST 6179(Day 14)
研究者
研究点 (1)
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