A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: AUCtau Day 14
研究概览
简要总结
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
详细描述
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
- •Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
- •Subject is Caucasian.
- •Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
- •Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
- •Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
- •Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day
- •Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.
排除标准
- •Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
- •Subject has clinically significant abnormalities on a 12 lead ECG done at screening
- •Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
- •Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
- •Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
研究组 & 干预措施
10 mg
single oral daily dose of 10 mg N91115 for 14 days
干预措施: N91115 (Drug)
Placebo
single oral daily dose of placebo for 14 days
干预措施: Placebo (Drug)
50 mg
single oral daily dose of 50 mg N91115 for 14 days
干预措施: N91115 (Drug)
50 mg (single dose)
single oral dose of 50 mg N91115
干预措施: N91115 (Drug)
250 mg
single oral daily dose of 250 mg N91115 for 14 days (fasted)
干预措施: N91115 (Drug)
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
干预措施: N91115 (Drug)
500 mg
single oral daily dose of 500 mg N91115 for 14 days
干预措施: N91115 (Drug)
Placebo-Day 1 only
Single oral dose of placebo (Day 1 only)
干预措施: Placebo-Day 1 only (Drug)
结局指标
主要结局
Pharmacokinetics: AUCtau Day 14
时间窗: Day 14
Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Pharmacokinetics: Day 1 Plasma Cmax Values
时间窗: Day 1
All subjects who completed sample collections for Day 1 plasma N91115
Safety and Tolerability of N91115
时间窗: 21 Days
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Pharmacokinetics: Plasma Cmax Values on Day 14
时间窗: Day 14
Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Pharmacokinetics: Day 1 AUClast
时间窗: Day 1
Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
次要结局
未报告次要终点