ISRCTN73749655进行中（未招募）Unknown
ongitudinal study to evaluate intra- and inter-individual variability of LRRK2 protein and related biomarkers in healthy participants
Arvinas (United States)0 个研究点目标入组 8 人开始时间: 2023年8月15日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 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
- 性别
- All
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 protocolspecific procedures.
- •5. Women of childbearing potential must use an effective form of contraception (e.g., oral contraceptive, condom use, IUD, abstinence of heterosexual intercourse) during the study.
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.
- •2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be
- •repeated to confirm eligibility or judged to be clinically irrelevant for healthy participants.
- •3. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (positive hepatitis B core antibody [anti-HBc] with negative hepatitis B DNA is acceptable), or hepatitis C virus (HCV) (treated/resolved hepatitis C with negative polymerase chain reaction [PCR] RNA is allowed).
- •4. Vital sign measurements outside the following ranges during screening:
- •- body temperature, >35C to =38C
- •- systolic blood pressure, >90 to =150 mm Hg
- •- diastolic blood pressure, >50 to =90 mm Hg
- •- pulse rate, >45 to =100 bpm
- •5. Abnormal findings in the resting ECG at screening defined as:
- •- QTcF> 450 or < 350 msec for men and QTcF> 470 or < 360 msec for women
- •- Notable resting bradycardia (HR < 40 bpm) or tachycardia (HR > 100 bpm)
- •- Other abnormal findings in the resting ECG as determined by the investigator
- •6. Females who have a positive serum or urine pregnancy test.
- •7. Female participant is pregnant, planning to become pregnant during the study conduct, or is breast feeding.
- •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.
- •9. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to day 1 of this study, or less than 5 half-lives, whichever is longer).
- •10. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent
- •11. Positive test for drugs of abuse at screening or at day 1.
- •12. Alcohol will not be allowed from at least 24 hours before screening or day 1.
- •13. Smoker of more than 10 cigarettes per day prior to screening or who use tobacco products equivalent to more than 10 cigarettes per day and unable to abstain from smoking whilst in the unit.
- •14. Is demonstrating excess in caffeine consumption (more than eight cups of coffee or equivalent per day).
- •15. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- •16. Loss or donation of blood over 500 mL within 3 months prior to screening or intention to donate blood or blood products during the study.
- •17. Any known factor, condit
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