NCT02650076已完成1 期
A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil
研究概览
简要总结
The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate receptor occupancy with SK-1405 dose and plasma concentration.
The secondary objective is to assess the safety and tolerability of SK-1405 in healthy, Caucasian, male subjects.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide written informed consent to participate in this study, as confirmed by signing the informed consent document(s).
- •Adult Caucasian male aged ≥20 and ≤50 years.
- •Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m
- •Height ≤ 190 cm.
- •Subject is a non-smoker or has not smoked in the past 6 months.
- •Subject is considered to be in good health in the opinion of the investigator.
- •Subject's pre-study clinical laboratory findings are within normal range.
- •Subject must be willing and able to comply with all protocol requirements.
排除标准
- •Use of prohibited medications as described in the study protocol.
- •Current known or suspected history of drug/solvent abuse.
- •Current known or suspected history of alcohol abuse or currently drinks in excess of 21 units per week.
- •Subjects who have consumed caffeine containing products within 24 hours prior to baseline PET-CT.
- •Any concurrent medical, surgical, or psychiatric condition that may affect the subject's ability to meet all protocol requirements during the study duration and/or any significant illness in the investigator's opinion in the 4 weeks before screening.
- •Participation in any other clinical study with an investigational drug/device within three months prior to the first day of dosing and after enrolment in the current study.
- •Subject has a positive result of HIV screen, hepatitis B screen or hepatitis C screen.
- •Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
- •Subject has donated 500 mL or more of blood within the three months prior to screening.
- •History of neurological conditions.
- •Participation in a research study or other radiation exposure which in conjunction with this study would result in additional ionisation radiation exposure exceeding 10 mSv within the last year.
- •A contraindication for MRI, including but not limited to, MRI-incompatible pacemakers, recent metallic implants, foreign body in the eye, or other indications as assessed by a standard pre-MRI questionnaire, that preclude the subject undergoing MRI scans.
- •Subject has claustrophobia.
- •Subjects who have consumed Saint John's wort, red wine, Seville oranges, grapefruit or grapefruit juice within 7 days prior to dosing.
- •Subject has a partner who is either pregnant or breastfeeding for the duration of the study.
研究组 & 干预措施
Healthy
Experimental
干预措施: SK-1405 (Drug)
结局指标
主要结局
The receptor occupancy of SK-1405 as measured by PET-CT imaging with [11C]-carfentanil
时间窗: up to 4 days
次要结局
未报告次要终点
研究者
研究点 (1)
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