A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BioCorRx Inc
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter: Cmax.
研究概览
简要总结
This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol intramuscular depot naltrexone injection.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide informed consent.
- •Female or male subjects aged 18-50 years old.
- •Without current non-remitted DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) - Substance Use Disorders diagnoses; subjects with a sustained remission diagnosis are not excluded.
- •In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
- •Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
- •Must agree to comply with all study requirements and be willing to complete entire study.
- •Females of childbearing potential and males willing to practice an effective method(s) of birth control for the duration of participation in the study (<1% failure rate per year).
排除标准
- •Is pregnant, is planning to become pregnant or breastfeed infants during the study.
- •Is currently treated with naltrexone or has had a naltrexone implant in the past 2 years or received Vivitrol treatment in the past year.
- •Clinically significant medical/psychological condition or abnormality at screening (i.e., physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings), including any diagnosis of Hepatitis B, Hepatitis C or HIV infection.
- •Presence of opiates, cocaine, methamphetamine or other significant drugs of abuse in the urine (as determined by urine drug test).
- •Any active hepatitis or hepatic failure or dysfunction evidenced by the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 1.5 times the upper limit of normal (1.5xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 2.5xULN, prolonged prothrombin time (international normalized ratio ≥1.7), ascites, or esophageal variceal disease.
- •Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric or neurological disorders that would compromise ability to complete the study.
- •Participation in a methadone program currently or within past 3 years, or 3 or more previous medically supervised detoxification treatments in past 3 years.
- •If a healthy volunteer fails one naloxone challenge, the subject will not be suitable for the study. The only exceptions will be made when a 'false positive' test result is received for the first test.
- •Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG).
- •Participation in a clinical trial within 30 days of screening.
- •Has a condition which requires or may require treatment with opioid based medication.
- •Is prone to skin rashes, irritation or has a chronic skin condition.
- •Alcohol Use Disorder diagnosis.
- •Has a predisposition to poor response to an implant site reaction, as judged by the study physician.
- •Has a history of keloid formation, connective tissue disease, e.g., scleroderma, or history of recurrent MRSA infections.
研究组 & 干预措施
BICX104
BICX104 is an eroding implantable pellet that contains 1 g naltrexone and 11 mg magnesium stearate that will be inserted subcutaneously. It will be administered once for 84 days.
干预措施: BICX104 (Drug)
Vivitrol
Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.
干预措施: Vivitrol (Drug)
结局指标
主要结局
Pharmacokinetic parameter: Cmax.
时间窗: 140 Days
Maximum observed mean plasma concentration \[Cmax\] of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tmax.
时间窗: 140 Days
Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Css.
时间窗: 140 Days
Changes in the mean observed steady state plasma concentration \[Css\] of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone.
时间窗: 140 Days
Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.
Pharmacokinetic parameter: AUC
时间窗: 140 Days
Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tlast.
时间窗: 140 Days
Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.
次要结局
- Safety Parameter: AEs(168 Days)