ACTRN12618000183280已完成1 期
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Parallel-Group, Relative Bioavailability Study to Evaluate the Pharmacokinetics of ZYN002 (CBD) Following Application to the Skin of the Upper Arms/Shoulders Compared to Upper Arms/Shoulders and Upper Thighs
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female adults, 18-70 years of age, inclusive, at the time of screening.
- •2. Judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable, must be documented as not clinically significant (NCS) at the discretion of the investigator.
- •3. Subjects must have a body mass index between 18-30.4 kg/m2, inclusive.
- •4. Females of childbearing potential must have a negative pregnancy test at Screening and a negative pregnancy test on Day -1 at admission to the CRU. If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months and with a follicle stimulating hormone (FSH) level > 40 IU/L or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
- •5. Males must consent to use a condom throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
- •6. Subject must agree to abide by all study restrictions and comply with all protocol requirements and study procedures.
排除标准
- •1. Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential, and male subjects with a partner of childbearing potential, who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 30 days after the last dose of study medication.
- •a. Standard acceptable methods include: males to use a condom, female participants and female partners of male participants who are women of child bearing potential to use an actual highly effective method of contraception (i.e. hormonal method with a <1% annual failure rate or an IUD), abstinence, and vasectomy.
- •2. Has eaten any food or drink/beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussel sprouts, or mustard), and charbroiled meats within one week prior to study start through the end of the study.
- •3. Use of tobacco/nicotine-containing products within one month of Screening Visit or during the study.
- •4. Use of any prescription drugs, except hormonal contraception, or herbal supplements within four weeks prior to Screening or any over-the-counter (OTC) drugs/vitamins within 72 hours prior to first dose of study medication through the End of Study Visit.
- •5. Use of cannabis or any CBD-containing product within four weeks of the Screening Visit or during the study.
- •6. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
- •7. Positive drug screen for ethanol, cocaine, delta-9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, and opiates at Screening and Day -1.
- •8. Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment.
- •9. Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
- •10. Use of cosmetics (excluding study moisturizer) on the shoulder/upper arms or upper thighs, during the study period.
- •11. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
- •12. History of treatment for, or evidence of alcohol or drug abuse within the past year or current alcohol consumption exceeding an average of two units of alcohol per day.
- •13. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements.
- •14. Has suspected or confirmed cardiovascular disease.
- •15. Participation in any investigational product or device study within 30 days prior to Screening Visit, or is scheduled to participate in an investigational device or another investigational drug study during the course of this study.
- •16. Subject responded yes” to Question 4 or 5 of C-SSRS during Screening and Day-1.
- •17. Demonstrates behaviour indicating unreliability or inability to comply with the requirements of
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