Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- oral bioavailability
研究概览
简要总结
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation.
This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner.
The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects will be eligible to participate in the study if all of the following conditions exist:
- •Males and females between the ages of 18-
- •Subjects are capable of giving informed consent.
- •Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
- •Subject should be medication free, other than study drug, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.
排除标准
- •Subjects will be excluded from participation in the study if any of the following conditions exist:
- •Women who are pregnant.
- •Women who are breast feeding.
- •Subject has a history of intolerance to IV administration of medication.
- •Subject has a known hypersensitivity to baclofen.
- •Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
- •Subject has taken or used any investigational drug or device in the 30 days prior to screening.
- •Subject has taken either prescribed or over the counter medication for 48 hours prior to baclofen administration on either of the study days.
- •Subject reveals clinically significant abnormalities on screening laboratory tests.
- •Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.
研究组 & 干预措施
Oral Baclofen
干预措施: Oral baclofen (Drug)
Intervenous baclofen
Crossover study that eacg subject is given both oral and intervenous baclofen
干预措施: Intervenous baclofen (Drug)
结局指标
主要结局
oral bioavailability
时间窗: 5, 15, 30 minutes, and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
oral bioavailability is the fraction of an administered dose of unchanged drug that reaches the systemic circulation
Maximum concentration (Cmax)
时间窗: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
The maximum concentration is the maximum baclofen concentration observed
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Tmax
时间窗: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Tmax is the time at which the maximum baclofen concentration was observed
Plasma Decay Half-Life (t1/2)
时间窗: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
次要结局
- Nystagmus(up to 12 hours following drug administration)
- assessment of sedation(up to 12 hours)
- Ataxia(up to 12 hours after infusion)
- blood pressure(5 minutes immediately prior to, and during the IV infusion and oral administration, then every 15 minutes for 1 hour, then every hour for 12 hours.)