NCT03535662已完成1 期
A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Male Participants to Determine the Effect of an Inhibitor of Cytochrome P450 3A and P Glycoprotein on Exposure to Orvepitant
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Exposure to orvepitant
研究概览
简要总结
A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.
Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant alone followed by orvepitant in combination with itraconazole.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male volunteers
- •judged to be in good health, based on the results of medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory findings
- •body weight greater than 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
排除标准
- •clinically significant findings on physical examination
- •relevant medical history
- •history of or considered at high risk of seizures (except febrile fits in childhood), including history of significant head injury
- •positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus (HIV)
- •serum biochemistry and full blood count considered by the Investigator to be of clinical significance
- •systolic blood pressure <100 or >140 mmHg or diastolic BP <50 or ˃90 mmHg, measured prior to the first dose of orvepitant
- •abnormal 12 lead electrocardiogram (ECG)
- •has donated one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study intervention administration
研究组 & 干预措施
Orvepitant
Experimental
Orvepitant single 20mg dose
干预措施: Orvepitant (Drug)
Orvepitant and itraconazole
Experimental
Orvepitant single 20mg dose in combination with repeat dose itraconazole
干预措施: Orvepitant (Drug)
Orvepitant and itraconazole
Experimental
Orvepitant single 20mg dose in combination with repeat dose itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Exposure to orvepitant
时间窗: 0 to 168 hours post dose
Area Under Curve (AUC)
次要结局
未报告次要终点
研究者
研究点 (1)
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