A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.
详细描述
Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005 and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled sequentially into a total of 5 ascending dose levels pending safety review, and PK review where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005 and 1 for placebo) were included as the first dose administered at each dose level in Period 1.
In Period 2, all subjects in the last three XG005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout period. Period 2 was open-label with 10 subjects per group.
PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Period 1: Participants and investigators were blinded Period 2: Open label
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
- •BMI range of 18-30 kg/m2
- •Medically healthy subjects
- •Creatinine clearance ≥ 80 mL/min
排除标准
- •History or presence of significant diseases
- •History or presence of alcoholism or drug abuse
- •Consumption of alcohol 48 hours prior each dose
- •Hypersensitivity or idiosyncratic reaction to the study drug
- •Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;
- •Donation (standard donation amount or more) of blood or blood products
- •Plasma donation within 7 days prior to the study;
- •Participation in another clinical trial within 30 days prior to the first dose;
- •Female subjects who are pregnant or lactating;
- •Hemoglobin < 120 g/L
研究组 & 干预措施
Period 1- XG005
XG005 capsule in 4 dose level
干预措施: XG005 (Drug)
Period 2- Naproxen and Pregabalin
Combination of Naproxen and Pregabalin
干预措施: Combination of Naproxen and Pregabalin (Drug)
Period 1- Placebo
XG005 matching placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: Day1 to Day 4
Time to maximum concentration (Tmax)
时间窗: Day1 to Day 4
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
时间窗: Day1 to Day 4
Terminal Elimination Rate Constant (kel)
时间窗: Day1 to Day 4
Terminal half-life (t1/2)
时间窗: Day1 to Day 4
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
时间窗: Day1 to Day 4
Terminal clearance (CL/F)
时间窗: Day1 to Day 4
Volume of distribution (Vd/F)
时间窗: Day1 to Day 4
次要结局
- respiratory rate(Day -1 to Day 8)
- temperature(Day -1 to Day 8)
- physical examination(Day -1 to Day 8)
- electrocardiogram (ECG) parameters;(Day -1 to Day 8)
- clinical laboratory parameters -chemistry(Day -1 to Day 8)
- clinical laboratory parameters- hematology(Day -1 to Day 8)
- incidence and severity of adverse events (AEs)(Day -1 to Day 8)
- blood pressure(Day -1 to Day 8)
- heart rate(Day -1 to Day 8)
- clinical laboratory parameters urinalysis(Day -1 to Day 8)