ISRCTN71330683进行中（未招募）1 期
A phase I non-randomized, open label, adaptive, parallel group, human positron emission tomography (PET) study to assess the occupancy of brain ?1 and ?2 containing GABAA receptors of RO7308480 using [11C]RO7285378 and [11C]flumazenil following single oral doses in healthy participants.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- All
入选标准
- •1. Participants aged 23- 55 years
- •2. Body mass index 18-32 kg/m²
- •3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
- •4. Able to communicate with study personnel
- •5. Reliable, willing, and likely to comply with the protocol
- •6. Willing to comply with the contraception requirements of the protocol
- •7. Consent to inform their GP of their participation in the study, and to enter their details into the over-volunteering database (TOPS).
排除标准
- •1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, MRI scan and laboratory safety tests of blood and urine);
- •2. Abuse of alcohol or drugs;
- •3. Serious reaction to any medicine;
- •4. Taken certain medicines (ones that could affect the breakdown of the study medicine or that affect the central nervous system or blood flow) during the 30 days before dosing; taken any medicine (except paracetamol), herbal remedies or dietary supplements during the 2 weeks before dosing; taken isotretinoin 2 years prior to screening;
- •5. History of ophthalmologic conditions that might affect the corneal surface (such as keratoconus, severe dry eye disease and/or corneal dystrophy); wear prescription contact lenses on a daily basis, unless they are not willing to switch to prescription glasses during the study, including the follow-up visit;
- •6. Have had any condition or operation that might affect the way the body absorbs medicines; have had any clinically significant disease; history of seizures or convulsion ‘fits’ (other than single benign febrile convulsion of childhood);
- •7. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of receptor occupancy
- •8. Tried to commit suicide or homicide, had suicidal or homicidal thoughts; mental illness might compromise consent;
- •9. Pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby;
- •10. Claustrophobia; any condition which would make it difficult to lie still for very long;
- •11. Metal in the body (eg pacemaker, mechanical heart valve, replacement hip joint, shrapnel); have worked as a metal worker, machinist or welder — due to increased risk from MRI scans
- •12. Exposure to ionising radiation as part of a research study, such that combined with the exposure from this study their effective dose in a 12 month period would exceed 10 mSv.
- •13. Unsatisfactory venous access or contraindication for arterial cannulation;
- •14. Participants who have donated ?500 mL of blood or blood products or had significant blood loss within 3 months prior to screening.
- •15. participants who use 5 or more cigarettes per day or equivalent amount of tobacco or nicotine products — because participants must be able comfortably to abstain from smoking during the study.
- •16. Alanine aminotransferase and total bilirubin above the upper limit of normal (ULN) (added 27/06/2023)
- •Criteria are designed to select healthy young participants, who are robust enough to recover quickly from any adverse effects of RO7308480.
研究者
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