A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
研究概览
简要总结
Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD). Having alternative injection sites is desirable to provide additional flexibility to patients, particularly for those who may prefer less visible or more convenient injection locations.
The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).
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
- •Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
- •Sex: male or female.
- •Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.
- •Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD), or documented history of moderate to severe OUD and receiving/stabilized on medicine for opioid use disorder (MOUD).
- •Body mass index: ≥ 18.0 to ≤ 33.0 kg/m^
- •New to treatment and seeking MOUD, or currently prescribed transmucosal (TM) buprenorphine (BUP) for OUD at the dose of 12 mg daily or can dose adjust to 12 mg daily.
- •Agree not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study.
排除标准
- •Has current diagnosis, other than OUD, requiring chronic opioid treatment.
- •Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.
- •Has target areas unsuitable for subcutaneous injections or evaluation of injections site (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study.
- •Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of SUBLOCADE or still recovering from prior such injury or surgery.
- •Known personal and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other medications that prolong the QT interval. Known family history of sudden unexplained death.
- •Currently taking (within the 30 days prior to signing the ICF) prescription or over-the-counter medications that are clinically relevant CYP 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals [eg, ketoconazole], macrolide antibiotics [eg, erythromycin]).
- •Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.
- •Has any active medical condition, or psychiatric illness, or social/legal situation (including court order requiring treatment for OUD), or organ disease, or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, or limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent.
- •Moderate or severe hepatic impairment (Child-Pugh B or C).
- •Has known allergy or hypersensitivity to BUP or any component of the ATRIGEL Delivery System.
- •Concurrent or has had prior treatment with any BUP long-acting injectable product (eg, SUBLOCADE) in the past 3 years prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.
- •Treatment with another investigational agent within 30 days prior to Screening or enrollment in another clinical study (except for an observational study).
- •Concurrent treatment with medications contraindicated for use with BUP as per local prescribing information.
- •Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff or Indivior employee).
研究组 & 干预措施
Extended-release Buprenorphine: Upper Arm
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
干预措施: Buprenorphine Extended-Release Injection (Drug)
Extended-release Buprenorphine: Thigh
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
干预措施: Buprenorphine Extended-Release Injection (Drug)
Extended-release Buprenorphine: Buttocks
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
干预措施: Buprenorphine Extended-Release Injection (Drug)
Extended-release Buprenorphine: Abdomen
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
干预措施: Buprenorphine Extended-Release Injection (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
时间窗: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
时间窗: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
次要结局
- Participants With Treatment-emergent Adverse Events(28 days)
- Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions(28 days)
- Number of Participants With Treatment-emergent Serious Adverse Events(28 days)
- Injection Site Grading(Day 1 at 10 minutes and 2 hours post dosing)
- Injection Site Pain(Day 1 at 1, 5, 10, 15, and 30 minutes post dosing)