NL-OMON53216已完成不适用
ongitudinal Study to Evaluate Intra- and Inter-Individual Variability of LRRK2 Protein and Related Biomarkers in Healthy Participants - Arvinas Biomarker Variability Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 18 - 70 years of age at screening (inclusive).
- •2. BMI in the range of 18 - 30 kg/m2, inclusive at screening and with a minimum
- •weight of 50 kg.
- •3. Able to speak, read, and understand study procedures in Dutch sufficiently
- •to allow completion of all study assessments.
- •4. Must understand and provide written informed consent prior to the initiation
- •of any protocol-specific procedures.
- •5. Women of childbearing potential must use a form of birth control (e.g., oral
- •contraceptive, condom use, IUD, abstinence of heterosexual intercourse) during
排除标准
- •1. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the participant in the
- •opinion of the investigator (following a detailed medical history, physical
- •examination, vital signs (systolic and diastolic blood pressure, pulse rate,
- •body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from
- •the normal range may be accepted, if judged by the Investigator to have no
- •clinical relevance.
- •5. Abnormal findings in the resting ECG at screening defined as:
- •- QTcF longer than 450 or shorter than 350 msec for men and QTcF longer then
- •470 or shorter then 360 msec for women
- •- Notable resting bradycardia (HR under 40 bpm) or tachycardia (HR over 100 bpm)
- •- Other abnormal findings in the resting ECG as determined by the investigator
- •8. Use of any medications (prescription or over-the-counter [OTC] including
- •herbal medication), within 14 days prior to the first blood collection on day
- •1, or less than 5 half-lives (whichever is longer), except for birth control,
- •paracetamol (up to 4 g/day), and ibuprofen (up to 1g/day). Other exceptions
- •will only be made if the rationale is clearly documented by the investigator.
- •18. For CSF sampling, any of the criteria below:
- •- History of clinically significant hypersensitivity to local anaesthetics that
- •may be used for LP (e.g., lidocaine).
- •- Criteria that would preclude an LP, such as a local infection at the site of
- •the LP, less then 100x 103/µl platelet count at screening or clinically
- •significant coagulation abnormality or significant active bleeding, or
- •treatment with an anticoagulant or treatment with more than 2 antiplatelet
- •- History of clinically significant back pathology and/or back injury (e.g.,
- •degenerative disease, spinal deformity, or spinal surgery) that may predispose
- •to complications or technical difficulty with LP.
研究者
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