A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Cmax
研究概览
简要总结
This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written, personally signed, and dated informed consent.
- •Healthy male and female participants between the ages of 18 to 45 inclusive.
- •BMI 18 - 30 kg/m
- •Non- or ex-smoker.
- •Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.
- •Participants must agree to use highly
排除标准
- •History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
- •Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
- •Previous or current alcohol, or other drug dependence.
研究组 & 干预措施
Noribogaine 60mg
1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
干预措施: Noribogaine (Drug)
Noribogaine 20mg
1 x Noribogaine 10mg capsule twice daily
干预措施: Noribogaine (Drug)
Noribogaine 80mg
2 x Noribogaine 20mg capsule twice daily
干预措施: Noribogaine (Drug)
Noribogaine 40mg
1 x Noribogaine 20mg capsule twice daily
干预措施: Noribogaine (Drug)
结局指标
主要结局
Pharmacokinetics Cmax
时间窗: Day 1 to Day 8
Determination of maximum plasma concentration of noribogaine
Pharmacokinetics Tmax
时间窗: Day 1 to Day 8
Determination of the time to reach the maximum plasma concentration of noribogaine
Pharmacokinetics AUC0-infinity
时间窗: Day 1 to Day 8
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Pharmacokinetics AUC0-t
时间窗: Day 1 to Day 8
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Pharmacokinetics t1/2
时间窗: Day 1 to Day 8
Determination of elimination half-life (t1/2) of noribogaine
次要结局
未报告次要终点