NCT02698267已完成1 期
An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of BIIB074
研究概览
简要总结
The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females.
- •Male or postmenopausal or surgically sterile females.
- •Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
排除标准
- •Females of childbearing potential.
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BIIB074
Experimental
Administered orally on Day 1 and Day 11
干预措施: BIIB074 (Drug)
BIIB074
Experimental
Administered orally on Day 1 and Day 11
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of BIIB074
时间窗: Prior to dosing up to 96 hours post dose
Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: Prior to dosing up to 96 hours post dose
次要结局
- Time that the maximum observed concentration occurs (Tmax) of BIIB074(Prior to dosing up to 96 hours post dose)
- Terminal elimination half-life (t1/2) of BIIB074(96 hours post dose)
- Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074(Prior to dosing up to 96 hours post dose)
- Apparent volume of distribution (Vd/F) of BIIB074(96 hours post dose)
- Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)(Up to 25 days)
- Number of participants with clinically significant vital sign abnormalities(Up to 25 days)
- Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)(Prior to dosing up to 96 hours post dose)
- Apparent total body clearance (CL/F) of BIIB074(96 hours post dose)
- Number of participants with clinically significant laboratory assessment abnormalities(Up to 25 days)
- Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)(Prior to dosing up to 96 hours post dose)
- Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities(Up to 25 days)
- Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)(Prior to dosing up to 96 hours post dose)
- Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)(Prior to dosing up to 96 hours post dose)
研究者
研究点 (1)
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