A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) in Comparison to Intermediate Molecular Weight (Reference Treatment) in Treatment-Seeking Subjects With Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
研究概览
简要总结
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD)
- •Is seeking treatment for OUD
- •Body mass index: ≥ 18.0 to ≤ 35.0 kg/m^2
- •Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from Screening through at least 6 months after the last dose of Investigational Medicinal Product (IMP).
- •Males: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
- •Have a normal electrocardiogram (ECG) or ECG with no clinically significant findings in the opinion of the Investigator or medically qualified sub-investigator at Screening and through pre-dose on Day
- •Agree not to take any buprenorphine-containing products, other than those administered for the current study, throughout the duration of the study.
- •Willing to adhere to study procedures and provide written informed consent prior to start of any study procedures.
排除标准
- •Current diagnosis, other than OUD, requiring chronic opioid treatment.
- •Pregnant or lactating females.
- •Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) > 450 msec in males and QTcF > 470 msec in females upon admission to the residential facility or prior to administration of RBP-
- •Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco.
- •Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
- •Used buprenorphine-containing products within the 14 days prior to signing the informed consent form.
- •Have a history of suicidal ideation within the 30 days prior to signing the informed consent form or prior to study drug administration
- •Have a history or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, naloxone, methadone, or the ATRIGEL Delivery System.
- •Individuals who have a positive urine drug screen (UDS) prior to admission to the residential facility for barbiturates, benzodiazepines, buprenorphine, or methadone.
研究组 & 干预措施
RBP-6000 - Light MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.
干预措施: RBP-6000 (Drug)
RBP-6000 - Light MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.
干预措施: SUBOXONE Sublingual Film (Drug)
RBP-6000 - Heavy MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
干预措施: RBP-6000 (Drug)
RBP-6000 - Heavy MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
干预措施: SUBOXONE Sublingual Film (Drug)
RBP-6000 - Intermediate MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).
干预措施: RBP-6000 (Drug)
RBP-6000 - Intermediate MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).
干预措施: SUBOXONE Sublingual Film (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
时间窗: Day 1 to Day 57
Relative bioavailability will also be assessed using Cmax
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
时间窗: Day 1 to Day 29
Relative bioavailability will be assessed using AUC0-28days.
次要结局
- Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine(Day 1 to Day 57)
- Participants with Treatment-Emergent Adverse Events(Day 1 to Day 57)
- Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine(Day 1 to Day 29)