ISRCTN57043417已完成1 期
A randomised, double-blind, placebo-controlled, phase 1 first-in-human study to investigate the safety, tolerability, pharmacokinetics, and food effect of single- and multiple-ascending doses of BEN8744 in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
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. Aged 18–65 years
- •2. Body mass index 18.0–30.9 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 of the protocol
- •7. Consent to our informing their GP of their participation in the study, and to our entering 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, and laboratory safety tests of blood and urine);
- •2. Abuse of alcohol or drugs
- •3. Taken prescription medicine or a COVID-19 vaccine during the 28 days before dosing; taken other medicine (except up to 2 g paracetamol), herbal remedies or dietary supplements during the 7 days before dosing; have had a serious reaction to any medicine
- •4. Have had any condition or operation that might affect the way the body absorbs medicines or have had any clinically significant disease
- •5. History of seizures or at risk of seizure (eg history of significant head trauma)
- •6. Significant suicidality history or suicidality risk (assessed by C-SSRS)
- •7. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of BEN8744. Mental illness might compromise consent.
- •8. Pregnant or breastfeeding or unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby
- •9. Have donated blood, or taken part in another study, within the past 3 months or don't agree not to donate blood, or take part in another study, during the 3 months after this study
- •10. Regular users of cigarettes or tobacco and/or nicotine-containing products (including e-cigarettes) in the 3 months before screening. Social smokers or vapers who smoke/vape in the 1 month before screening.
- •11. Unwilling to eat a high-fat breakfast containing bacon — because, to study the effects of food on blood levels of the study medicine, we must give all participants the standard high-fat breakfast specified by the US Food and Drug Administration (Part B only)
研究者
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