ISRCTN36003543进行中（未招募）1 期
A single-center, non-randomized, open-label, parallel group, adaptive, phase I positron emission tomography (PET) study to assess the brain occupancy following single oral doses of RO7268489 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
- 16
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 who are overtly healthy (defined by absence of evidence of any active or chronic disease).
- •2. Body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m²) inclusive.
排除标准
- •1. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy, cholecystectomy and hernia repair).
- •2. Confirmed (based on the average of 3 consecutive measurements) systolic blood pressure greater than 140 or less than 90 millimeters of mercury (mmHg) and diastolic blood pressure greater than 90 or less than 45 mmHg at screening
- •3. Confirmed (based on the average of 3 consecutive measurements) resting pulse rate greater than 90 or less than 40 beats per minute (BPM) at screening.
- •4. Participants who have a history of migraine.
- •5. Any clinically significant history of hypersensitivity (e.g., drugs, excipients) or allergic reactions.
- •6. Contradiction for arterial cannulation. Allen’s test indicating potential risk in placement of the arterial cannula.
- •7. Participation in an investigational drug or device study within 90 days prior to dosing, as calculated from the day of follow-up from the previous study or within 30 days as assessed by the investigator
- •8. Participation in an investigational drug study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months prior to dosing as calculated from the day of follow-up from the previous study
- •9. Participants who are pregnant, lactating, or breastfeeding.
研究者
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