NCT00805454已完成1 期
A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.
研究概览
简要总结
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
详细描述
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
- •BMI between 19 and 32 kg/m2, inclusive.
排除标准
- •Condition or history which may present a safety concern to the subject or interfere with outcome variables.
- •History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.
- •Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.
- •Use of tobacco products or daily exposue to second hand smoke.
- •Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.
- •History of serious mental disorder.
结局指标
主要结局
Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.
时间窗: 10 days
次要结局
- Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests(30 days)
研究者
相似试验
已完成
1 期
Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy VolunteersHealthy VolunteersNCT06300580AbbVie11
已完成
1 期
A Study of Dopamine Type 2 (D2) Receptor Occupancy Following a Single Oral Dose of OROS PaliperidoneSchizophreniaNCT00796432Johnson & Johnson Pharmaceutical Research & Development, L.L.C.4
已完成
不适用
Change in Brain Metabolism and Cognitive Function by AripiprazoleAntipsychoticsCognitionBrain MetabolismDopamine Receptor OccupancyNCT01562808Seoul National University Hospital15
已完成
1 期
Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242SchizophreniaNCT02824666Braeburn Pharmaceuticals7
已完成
早期 1 期
D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562Healthy Male VolunteersNCT03686501Invicro6