ACTRN12623000730606已完成1 期
A Phase 1, 2-Part, Open-Label, Pilot Trial to Assess the Relative Bioavailability of 3 Formulations of Cannabidiol (CBD) under FASTED (Part A) and FED (Part B) conditions in Healthy Adult Male Subjects
Sapient Therapeutics (Australia) PTY Ltd0 个研究点目标入组 15 人开始时间: 2023年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •1.Male, non-smoker (no use of tobacco or nicotine products within 1 month prior to screening), aged between 18 and 55 years (inclusive), with BMI >18.0 and <32.0 kg/m2 and body weight greater than or equal to 50.0 kg.
- •2.No know allergic reaction to cannabis products with previous use.
- •3.No known allergic reaction to sesame oil (Epidiolex is formulated in sesame oil).
- •4. Must have hepatic and renal clinical laboratory test results (ALT, AST, total bilirubin and eGFR) within a laboratory defined normal range.
- •5.Must be abstinent from heterosexual intercourse or agree to use an acceptable form of contraception with a female sexual partner of childbearing potential.
- •6.Refrain from donating sperm for the duration of the study and for at least 90 days after the last dose of IP.
- •7.Adequate venous access in both arms for collection of a number of blood samples.
- •8.Willing to take off dentures or mouth piercings at the time of dosing.
- •9.Willing and able to adhere to all protocol requirements, including willingness to comply with scheduled visits, and consume high-fat, high-calorie meal.
- •10.Able to understand the study procedures and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1.Any clinically significant illness or disease (in the opinion the Investigator) as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
- •2.History of inherent cardiac abnormalities based on the opinion of the Investigator.
- •3.Clinically significant ECG abnormalities (QTcF > 450 ms), or clinically significant vital sign abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, HR less than 45 or over 100 bpm, or RR less than 8 or over 22 resp/min) at screening.
- •4.Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at screening.
- •5.Presence of current psychiatric condition, suicide ideations or psychiatric condition requiring pharmacological management within the last 6 months, presence of current or history of psychosis/schizophrenia and bipolar disorders.
- •6.History of gastrointestinal disorders which may have impacted absorption, distribution, metabolism and/or excretion of the IPs (such a cholecystitis, cholecystectomy, Gilbert’s syndrome).
- •7.Positive urine drug screen, urine cotinine test at screening or Day -1, 7±7, 14±7 and 28±7
- •8.Positive alcohol breath test at screening or at admissions on Days 1, 7±7, 14±7 and 28±7.
- •9.Known allergic reactions to any excipient in the formulations.
- •10.History of significant drug abuse within 1 year prior to screening or use of drugs such as marijuana within 1 month prior to the screening visit or drugs such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
- •11.Patients with current or past history of acute or chronic liver disease of any aetiology
- •12.Active hepatitis – chronic or acute
- •13.History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
- •14.Use of medications for the timeframes specified below, with the exception of medications exempted by the PI on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
- •a)Prescription medications within 14 days prior to the first dose until end of the study;
- •b)Any vaccination, within 1 month prior to the first dose through to EOS;
- •c)Over-the-counter products and natural health products (including herbal remedies such as St. John’s wort, homeopathic and traditional medicines), within 7 days prior to the first dose up to EOS, with the exception of the occasional use of paracetamol (up to 2 g daily) and ibuprofen (up to 1.2 g daily). Probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements are allowed;
- •d)Any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first dose.
- •15.Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or a minimum of 5 half-lives, whichever is longer) prior to the first dose, administration
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