A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B).
研究概览
简要总结
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated.
This study has 2 parts: Part A and Part B.
详细描述
This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).
The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.
In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.
The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency.
Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,
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
- •Healthy male or female subjects 18 to 55 years of age
- •Current opioid users who have used opioids for recreational (non-therapeutic) purposes
排除标准
- •Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
- •Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
- •History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
- •History or presence of any clinically significant illness
- •History of major mental illness that may affect the ability of the subject to participate in the study.
研究组 & 干预措施
Placebo
Placebo
150 mL flavored beverage
干预措施: Placebo solution (Drug)
90 mg nalbuphine HCl solution
90 mg nalbuphine HCl solution
9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
120 mg nalbuphine HCl solution
120 mg nalbuphine HCl solution
12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
150 mg nalbuphine HCl solution
150 mg nalbuphine HCl solution
15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
180 mg nalbuphine HCl solution
180 mg nalbuphine HCl solution
18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
270 mg nalbuphine HCl solution
270 mg nalbuphine HCl solution
27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
Up to 405 mg nalbuphine HCl solution
Up to 405 mg nalbuphine HCl solution
Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
Up to 540 mg nalbuphine HCl solution
Up to 540 mg nalbuphine HCl solution
Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage
干预措施: Nalbuphine HCl solution (Drug)
结局指标
主要结局
To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B).
时间窗: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max
次要结局
未报告次要终点