ISRCTN42835524已完成1 期
A Phase 1 Single- and Multiple-Ascending Dose Study of the Safety and Pharmacokinetics of a Gastro Retentive Formulation of 5-Hydroxytryptophan (5-HTP) and Low-Dose Carbidopa (EVX-101) in Healthy Subjects Taking Escitalopram
Evecxia Therapeutics Inc.0 个研究点目标入组 38 人开始时间: 2022年3月2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
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 21/04/2023:
- •1. Healthy males or non-pregnant, non-lactating healthy females
- •2. Aged 18 to 55 years old for Part 1 and aged 25 to 55 years old for Part 2 inclusive at the time of signing informed consent
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- •4. Weight =50 kg at screening
- •5. Must be willing and able to communicate and participate in the whole study
- •6. Must provide written informed consent
- •7. Must agree to adhere to the contraception requirements defined in the clinical protocol
- •Previous participant inclusion criteria:
- •Healthy volunteer
排除标准
- •Current participant exclusion criteria as of 21/04/2023:
- •1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •2. Subjects who are, or are immediate family members of, a study site or sponsor employee
- •3. Subjects who have previously received 5-HTP/Carbidopa in study EVX101-101/QSC201140
- •4. Subjects who have previously been administered IMP (5-HTP/carbidopa GR tablet or placebo) in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2
- •5. Evidence of current SARS-CoV-2 infection within 4 weeks of Day 1
- •6. History of any drug or alcohol abuse in the past 2 years
- •7. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- •8. A confirmed positive alcohol breath test at screening or Day 1
- •9. Results at screening indicative of chronic excess alcohol intake
- •10. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or Day 1
- •11. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •12. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive pregnancy test)
- •13. Male subjects with pregnant or lactating partners
- •14. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •15. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed
- •16. Platelet count, serum sodium, potassium or magnesium below the lower limit of the reference range at screening. For Part 2 only, haemoglobin below the lower limit of the reference range at screening
- •17. Clinically significant findings on ECG or vital signs as assessed by the investigator at screening or Day 1
- •18. QTcF >450 msec at screening or Day 1 or known QT interval prolongation or congenital long QT syndrome
- •19. Confirmed positive drugs of abuse test result
- •20. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •21. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or neurological disorder, as judged by the investigator
- •22. History of any psychiatric disease requiring treatment in the last 5 years
- •23. Known history of glaucoma or raised intraocular pressure
- •24. Presence or history of any GI disease including peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease
- •25. Subjects with a history of cholecystectomy or gall stones
- •26. Subjects unwilling to eat at least 90% of the pre-dose meals
- •27. Subject answers yes to Suicidal Ideation Items 1 or 2 on the C-SSRS (lifetime) at screening or Day 1
- •28. Serious adverse reaction or serious hypersensitivity to any drug (including serotonergic drugs such as anti-depressants and migraine medication) or the formulation excipients
- •29. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •30. Donation of blood or plasma within the previous 3 months or loss of g
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