NL-OMON52457已完成不适用
A Non-Randomized, Open Label, Adaptive, Single Center, Positron Emission Tomography (PET) Study to Assess Distribution of RO7248824 in the Central Nervous System Following Single Intrathecal Doses of [89Zr]-Labeled RO7248824 in Healthy Male Participants - Pet study to assess distribution of RO7248824 in the cns
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Able and willing to provide written informed consent and to comply with the
- •study protocol according to ICH and local regulations
- •2. Aged 25 to 55 years at the time of dosing
- •3. Overtly healthy (defined by absence of evidence of any active or chronic
- •disease) as determined by medical evaluation including:
- •- A detailed medical and surgical history
- •- A complete physical and neurological examination
- •- Vital signs
- •- 12-lead ECG
- •- Hematology
- •- Coagulation
- •- Blood chemistry
- •- Serology and urinalysis
- •4. Fluent in the language of the Investigator and study staff, and able to
- •communicate with the study staff
- •5. Body mass index of 18 to 30 kg/m2 at screening
- •6. Male participants only who, for 3 months after the dosing of RO7248824,
- •- Remain abstinent or use contraceptive barrier measures such as a condom, with
- •a female partner of childbearing potential, or pregnant female partner, to
- •avoid exposing the embryo
- •- Refrain from donating sperm
- •The reliability of sexual abstinence for male enrollment eligibility needs to
- •be evaluated in relation to the duration of the clinical study and the
- •preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,
- •calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal
- •are not acceptable methods of preventing drug exposure.
排除标准
- •1. Any condition or disease detected during the medical interview/physical
- •examination that would render the participant unsuitable for the study, place
- •the participant at undue risk or interfere with the ability of the participant
- •to complete the study, as determined by the Investigator
- •2. History or presence of cardiovascular, respiratory, hepatic, renal,
- •gastrointestinal, endocrine, hematological, or neurological disorders capable
- •of significantly altering the absorption, metabolism, or elimination of drugs;
- •constituting a risk when taking the study treatment; or interfering with the
- •interpretation of data
- •3. History or presence of clinically significant cardiovascular disease in the
- •opinion of the Investigator, including, but not limited to: left ventricular
- •ejection fraction < 40%, (assessed by echocardiogram/multiple-gated acquisition
- •scan [ECHO/MUGA]) congestive heart failure Class IV New York Heart Association
- •(NYHA), left ventricular outflow obstruction (aortic stenosis, idiopathic
- •hypertrophic subaortic stenosis), symptomatic coronary artery disease, prior
- •myocardial infarction,
- •congestive heart failure requiring hospitalization, prior cerebrovascular
- •4. History or presence of an abnormal ECG that is clinically significant in the
- •Investigator's opinion (e.g., PQ/PR interval > 220 ms, QTcF > 450 ms)
- •5. Uncontrolled arrhythmias or history of clinically significant arrhythmias
- •including: ventricular arrhythmias or risk factors for ventricular arrhythmias
- •(such as clinically significant electrolyte abnormalities (e.g., hypokalemia,
- •hypomagnesemia, hypocalcemia); second- or third-degree atrioventricular block;
- •family history of sudden unexplained death or long QT syndrome; congenital
- •hypertrophic or dilated cardiomyopathy
- •For the complete overview see the protocol
研究者
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