ACTRN12619000443190招募中1 期
A double-blind, randomized, two-period, two treatment, fixed sequence, crossover (fed versus fasted) study to evaluate the effect of food on pharmacokinetics of CBD with robust ECG monitoring in Healthy Volunteers (HVs)
Kalytera Australia Pty Ltd0 个研究点目标入组 32 人开始时间: 2019年3月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1.Healthy adult subjects =18 – 60 years of age
- •2.Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive and a minimum weight of at least 50 kg at screening and not more than 100 kg at screening
- •3.Non-users of tobacco or nicotine-containing products (minimum of 4 weeks from admission)
- •4.Subjects with reproductive potential required to practice abstinence or be using and willing to continue using a medically acceptable form of birth control for at least one month prior to screening (at least 3 months for oral contraceptives) and for at least 60 days after the last study drug administration.
- •5.Free from any clinically significant abnormality based on medical history, vital signs, physical examination, ECG, and laboratory evaluation at screening and admission to the treatment session, as judged by the investigator or designee.
- •6.Systolic blood pressure between 90 to 140 mmHg and diastolic blood pressure between 50 and 90 mmHg at screening and admission to the treatment session.
- •7.Male Participants who agree to the following during their participation in this study and for at least 1 month after the last dose of study intervention: Refrain from donating sperm PLUS either:
- •oBe abstinent from heterosexual [or homosexual] intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below:
- •oAgree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
- •8.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •oIs not a woman of childbearing potential (WOCBP) OR
- •oIs able to abstain from heterosexual intercourse if it is in keeping with her preferred and usual lifestyle (such as participants with same-sex partners)
- •oIs a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), during the intervention period and for at least 30 days plus 30 days (a menstrual cycle) after the last dose of study intervention [and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.]. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- •oA WOCBP must have a negative pregnancy test [ serum] as required by local regulations) within [24 hours] before the first dose of study intervention.
- •9.Subjects must be able to speak, read and understand English sufficiently to understand the nature of the study and provide written informed consent
- •10.Subjects must be capable of giving signed informed consent and agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •11.Subjects must have understood and provided written informed consent prior to initiation of any protocol-specific procedures.
排除标准
- •1.History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal or other major disease as determined by the Investigator and/or Sponsor’s Medical Monitor
- •2.Evidence of disease that may influence the outcome of the study within 4 weeks before dosing as determined by the Investigator and/or Sponsor’s Medical Monitor
- •3.Any history of gastrointestinal surgery that may affect the pharmacokinetic profile of the study drug
- •4.Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG findings or laboratory test results that requires medical treatment at Screening or Baseline
- •5.History of any medical condition which, in the opinion of the Investigator, may interfere with study procedures or compromise subject safety (e.g. psychiatric illness, disability or social situation)
- •6.Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
- •7.Known history of clinically significant food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
- •8.Active viral hepatitis (B or C) and HIV as demonstrated by positive serology at Screening
- •9.Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
- •10.Alanine transaminase (ALT) >1.5x upper limit of normal (ULD)
- •11.Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if fractionated and direct bilirubin <35%)
- •12.Persistent systolic blood pressure (BP) > 140 mmHg or < 90 mmHg and diastolic BP >90mmHg or <40mmHg at Screening or Baseline
- •13.Heart rate <50 or >100 beats/minute at Screening
- •14.History of prolonged QT/QTc interval
- •15.A history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/QTc interval
- •16.Corrected QT interval (QTc) >450 milliseconds (msec) (for males) or >470 msec (for females)
- •The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine-read or manually over-read
- •The specific formula that will be used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
- •For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used
- •17.A history of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- •18.History of myocardial infarction or active ischemic heart disease
- •19.History of clinically significant arrhythmia or uncontrolled arrhythmia
- •20.Intake of caffeinated beverages or food within 72 hours before dosing
- •21.Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (e.g. grapefruit, grapefruit juice, apple or orange juice, vegetables from the mustard green family) within 1 week before dosing. Alcohol within 72 hours of dosing.
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