Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 when given to healthy male volunteers.
详细描述
The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects aged between 18 and 45 years
- •BMI 18-30 kg/m2
- •Weight 55-90kg
- •Written informed consent
- •Good General Health
排除标准
- •Vulnerable subjects
- •Veins unsuitable for repeated venipuncture
- •Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
- •History of or positive test for drug abuse
- •Any condition requiring regular concomitant medication
- •Blood donation or significant loss of blood within 3 months prior to screening
- •Abnormal 12 lead ECG finding of clinical relevance
- •Heart rate (HR) <50bpm or >90bpm after 10 minutes in a supine position
- •Systolic blood pressure <90mmHg or >140mmHg after 10 minutes in a supine position
- •Diastolic blood pressure <50mmHg or >90mmHg after 10 minutes in a supine position
- •Abnormal 24 hour Holter recording of clinical relevance at screening
- •Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
研究组 & 干预措施
ODM-103
Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
干预措施: ODM103 (Drug)
Placebo
Oral capsules given once daily for one day or three times daily for 7 days
干预措施: Placebo (Drug)
entacapone + levodopa/carbidopa
entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
干预措施: Entacapone (Drug)
entacapone + levodopa/carbidopa
entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
干预措施: Levodopa/carbidopa (Drug)
结局指标
主要结局
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
时间窗: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
次要结局
- Area under the plasma concentration curve (AUC)(0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose)