ACTRN12622000289718已完成1 期
A Phase I Clinical Trial of IHL-675A to Assess Safety and Pharmacokinetics in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy volunteers will be included in the study if they satisfy all the following criteria:
- •1.Ages 18 to 65
- •2.BMI 18 to 32
- •3.QTcF <450 msec (males), <470 msec (females) at screening
- •4.No known allergic reaction to cannabis products with previous use
- •5.No known allergic reaction to sesame oil (Epidiolex is formulated in sesame oil)
- •6.Have no history of past substance abuse or current abuse of illicit drugs as defined by
- •a negative DOA test at screening
- •7.Physically well, in the opinion of the investigator, with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, bleeding, thyroid, cholesterol, or hypertension disorders
- •8.If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from 14 days prior to Visit Day 1 through to the end of the study. Subjects must agree to continue to use two approved methods of contraception including the use of a condom for 90 days following the administration of the study drug, and not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
- •a.Approved methods of contraception;
- •i.Inter-uterine device (IUD) in place for at least 3 months prior to Visit Day 1 through 30 days following the final dosing of the study drug
- •ii.Barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 90 days following the last administration of the study drug.
- •iii.Stable hormonal contraceptive for at least 3 months prior to Visit Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 90 days following the last administration of the study drug.
- •iv.Surgical sterilization (vasectomy) at least 6 months prior to Visit Day 1.
- •9.Females of non-childbearing potential who have established serum FSH levels >40mlU/ml (determined during screening) are either postmenopausal or have undergone one of the following sterilization procedures at least 6 months prior to Visit Day 1;
- •a.Bilateral tubal ligation
- •b.Hysterectomy
- •c.Hysterectomy with unilateral or bilateral oophorectomy
- •d.Bilateral oophorectomy
- •10.Females of childbearing potential that are not currently pregnant, lactating, or planning to be pregnant and agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from 14 days prior to Visit Day 1 through to the end of the study. Subjects must agree to continue to use two approved methods of contraception for 30 days following the administration of the study drug. In the event that the sexual partner is surgically sterile, contraception is not necessary.
- •a.Approved methods of contraception to use in conjunction with a condom;
- •i. Inter-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug
- •ii.Barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through to 30 days following the last administration of the study drug.
- •iii.Stable hormonal contraceptive for at least 3 months prior to Visit Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Visit Day 1 through to 30 days following the last administration of the study drug.
- •iv.Surgical sterilization (vasectomy) at least 6 months prior to Visit Day 1.
- •11.Not taking any vitamins, herbal remedies, or supplements wi
排除标准
- •Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening, or prior to dosing at the timepoints in the Schedule of Events
- •1.Family history of QT issues
- •2.History of significant psychiatric illness (defined as hospitalisation), suicidal ideation, or suicidal attempts
- •3.History of alcohol abuse or excessive alcohol intake
- •4.Positive urine drug test at screening
- •5.Positive alcohol breath test at screening
- •6.GAD-7 score of 15 or greater, MDI score 31 or greater OR 3 core symptoms and 5 accompanying symptoms, C-SSRS score of 4 or greater, OR reported suicidal behaviour within the past 3 months
- •7.Any dietary requirements incompatible with study breakfast; must be able to eat high-fat, high-calorie diet
- •8.In the opinion of the investigator other serious medical conditions
- •9.Hepatic or renal impairment or disease. Defined as AST/ALT greater than 1.5 x ULN, eGFR less than 60 at screening.
- •10.Subject has a history of cardiac disease or arrythmias
- •11.History of gastrointestinal disorders which may impact absorption, distribution, metabolism and/or excretion of the IP (such as cholecystitis, cholecystectomy, Gilbert’s syndrome)
- •12.Inability to adhere to medication restrictions during the study period
- •13.Participation in another clinical trial of an investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to study drug administration.
- •14.Inability to adhere to the protocol
- •15.Any other reason in the opinion of the investigator
研究者
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