NCT04175132终止1 期
Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4)
研究概览
简要总结
A study to learn how foliglurax binds in regions of the brain
详细描述
To study binding of foliglurax to mGlu4 receptors in human brain, up to 9 healthy subjects (Part A) and up to 8 patients with Parkinson's disease (Part B) will be injected with a liquid dose of a radiolabelled tracer that allows measurement of foliglurax binding in the brain to determine to which degree foliglurax binds to regions of the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •The subject has a normal structural MRI (sMRI) scan performed in the screening period, as judged by the investigator.
- •The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- •The subject can tolerate confined spaces for prolonged periods of time.
- •The subject is suitable for radial and/or brachial artery blood sampling and cannulation.
- •Patients with Parkinson's disease
- •The subject has a normal sMRI scan performed in the screening period, as judged by the investigator.
- •The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- •The patient has been diagnosed with idiopathic Parkinson's disease for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the OFF state.
- •The patient has dyskinesia that is not too severe to cause discomfort for the patient during PET imaging and predictable OFF time
- •In addition to the above criteria, the patient must, in the opinion of the investigator, also be suitable for the study and the included PET imaging sessions.
- •The patient has been receiving a stable regimen of levodopa-containing therapy (total levodopa dose ≤1600 mg per day) (≥3 doses per day of standard levodopa or ≥3 doses per day of carbidopa and levodopa, sustained-release tablets or extended-release capsules of carbidopa and levodopa or benserazide and levodopa), and be on a stable regimen of permitted anti-Parkinsonian drugs (peripheral decarboxylase inhibitors, dopamine agonists [except apomorphine], monoamine oxidase type B [MAO-B] inhibitors [except safinamide], or catechol-O-methyl transferase [COMT] inhibitors) for ≥4 weeks prior to foliglurax dosing
- •The patient can tolerate confined spaces for prolonged periods of time
- •The patient is suitable for radial and/or brachial artery blood sampling and cannulation
排除标准
- •The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Healthy subjects
Experimental
干预措施: foliglurax (Drug)
PD patients
Experimental
干预措施: foliglurax (Drug)
结局指标
主要结局
Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4)
时间窗: From Day 1 up to Day 3
in Healthy Participants and in Patients With Parkinson's Disease
C(PET) foliglurax
时间窗: From Day 1 up to Day 3
mean plasma concentration of foliglurax during PET measurement in Healthy Participants and in Patients With Parkinson's Disease
次要结局
- AUC(0-24) foliglurax(From Day 1 up to Day 3)
- Cmax foliglurax(From Day 1 up to Day 3)
- Tmax foliglurax(From Day 1 up to Day 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male ParticipantsHealthy ParticipantsNCT05320302H. Lundbeck A/S6
已完成
1 期
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male ParticipantsHealthy Young MenNCT05306366H. Lundbeck A/S8
终止
1 期
Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain TumorsAdult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Central Nervous System Germ Cell TumorAdult Choroid Plexus TumorAdult CraniopharyngiomaAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Grade I MeningiomaAdult Grade II MeningiomaAdult Grade III MeningiomaAdult MedulloblastomaAdult Meningeal HemangiopericytomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Pilocytic AstrocytomaAdult PineoblastomaAdult PineocytomaAdult SubependymomaAdult Supratentorial Primitive Neuroectodermal Tumor (PNET)Meningeal MelanocytomaNCT00110032National Cancer Institute (NCI)46
已完成
1 期
A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the BrainHealthyNCT04538014H. Lundbeck A/S8
撤回
1 期
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT03316898Allergan