A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Bioavailability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female 55 and over
- •No clinically important abnormal physical finding
- •No clinically significant lab results
- •Normal ECG
- •Normal BP and HR
- •BMI between 19 and 32
- •Weight 50 to 100 kg
- •Able to communicate
- •Provide written informed consent
- •Non smokers
- •Males to use contraception
- •Females to be surgically sterile or post menopausal
排除标准
- •Administration of any IMP other than study drug within 12 weeks before entry
- •Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
- •Surgical or medical condition that might interfere with IMP
- •History of drug or alcohol abuse
- •Clinically significant allergy requiring treatment
- •Loss of greater than 400ml of blood within 12 weeks.
- •Serious adverse reaction or hypersensitivity to any drug
- •Presence of Hep B, Hep c or HIV-1 or HIV-2 at screening
- •Presence of G6PD at screening
- •History of methaemoglobinaemia
- •Partner who is pregnant of lactating
- •Positive Pregnancy test
研究组 & 干预措施
TRx0037
Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics
干预措施: TRx0037 (Drug)
结局指标
主要结局
Bioavailability
时间窗: 19 Days (7-10 day follow up)
The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.
Pharmacokinetics
时间窗: 19 Days (7-10 day follow up)
The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.
Safety and tolerability
时间窗: 19 Days (7-10 day follow up)
Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037
次要结局
未报告次要终点