ISRCTN51560494已完成1 期
A Phase I, single-centre, open-label, crossover study in healthy volunteers using scintigraphy to evaluate the gastrointestinal behaviour of EDP2939 oral dosage forms
Evelo Biosciences Inc.0 个研究点目标入组 12 人开始时间: 2023年6月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Male subjects between 18 and 60 years of age inclusive
- •2. Body weight between >50.0 kg
- •3. Body mass index between 18 and 30 kg/m², inclusive
- •4. Understands and is willing, able and likely to comply with all study procedures including consumption of meals provided and restrictions
- •5. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities
- •6. Good general health with (in the opinion of the Principal Investigator [PI], or medically qualified designee) no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results.
- •7. Unless the subject has had a vasectomy (with confirmed sterility) more than 12 weeks prior to the study starting, must be willing to abstain from sexual intercourse and be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent for 90 days after the last dose of IMP, with women of childbearing potential for the duration of the trial and for 90 days after the last assessment visit OR agree to use a condom during each episode of penile-vaginal intercourse, in addition to female their partner (if a person who could become pregnant) using a highly effective form of contraception.
排除标准
- •1. Medical history:
- •1.1. Current or recurrent disease/condition that, in the opinion of the PI or medically qualified designee responsible, could affect study conduct; the safety of the subject as a result of participation; and/or the ability of the subject to complete the study or laboratory assessments. For example: hepatic disorders, renal insufficiency, congestive heart failure, conditions known to impact gastric emptying such as migraine or diabetes mellitus and relevant non-self-limiting GI disorders.
- •1.2. Current or relevant previous history of severe or unstable psychiatric illness, that may require treatment or make the subject unlikely to fully complete the study, or that presents undue risk from the study medication or procedures
- •1.3. History of previous surgical intervention which could affect GI transit and/or function for example gastric surgery, vagotomy or known adhesions with previous obstructive symptoms
- •1.4. Haematological or biochemical blood test at screening outside normal ranges and deemed clinically significant by the PI or medically qualified designee
- •1.5. Any contraindication to the gamma scintigraphy procedure
- •1.6. As a result of a physical examination or screening investigations available prior to dosing evaluations, the PI or medically qualified designee/physician responsible considers the volunteer unfit for the study
- •1.7. Measured body temperature >38°C (infection control procedure)
- •2. Medications:
- •2.1. Subject is scheduled to take prescribed medication within 14 days prior to the first or any subsequent assessment visit which, in the opinion of the PI or medically qualified designee responsible, will interfere with the study procedures or has the potential to affect gastric emptying and/or gut transit or compromise safety
- •2.2. Subject is scheduled to take over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to the first or any subsequent assessment visit unless approved by the PI or medically qualified designee
- •3. Alcohol/substance abuse:
- •3.1. Recent history (within the last year) of alcohol or other substance abuse
- •3.2. Subject has an average weekly alcohol intake of greater than 14 units
- •3.3. Subject has positive urine drugs of abuse test at screening or prior to dosing evaluation
- •3.4. Subject has a positive breath alcohol test at screening or prior to dosing evaluation
- •4. Smoking:
- •4.1. Subject has recently discontinued smoking (less than 3 months)
- •4.2. Subject is currently a smoker or user of nicotine-containing products
- •4.3. Subject has a positive urine cotinine test at screening or prior to dosing evaluation
- •5. Allergy/intolerance:
- •5.1. Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the PI or medically qualified designee responsible, contraindicates their participation
- •5.2. Subject has an allergy to any of the contents of the standardised meals
- •5.3. Subject is vegetarian or vegan
- •6. Clinical Studies
- •6.1. Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before the screening visit, or five elimination half-lives of the previous study drug, whichever is longer
- •6.2. Subject whose participation in this study will result in participation in more than four studies over a 12-month period
- •7. Personnel:
- •7.1. An employee of the Sponsor or study site or members of their immediate
研究者
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