An Open Label, Phase 1 Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of a Single Oral Dose of [14C]-BIIB122 ([14C] DNL151) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
研究概览
简要总结
This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of [14C] BIIB122 ([14C] DNL151) following a fast. The mass balance, excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •For men who choose to have sex with women, either: vasectomy, use of condoms, or sex with a woman who is of non-childbearing potential
- •Body mass index ≥18.0 kg/m2 and ≤32.0 kg/m2
- •Body weight ≥5.0 kg and ≤100.0 kg
- •Considered to be in good health
- •Non-smoker
排除标准
- •History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives
研究组 & 干预措施
Cohort A
干预措施: [14C] BIIB122 ([14C] DNL151) (Drug)
结局指标
主要结局
PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
时间窗: 43 days
PK Parameter: Maximum observed plasma concentration (Cmax) occurring at Tmax for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
时间窗: 43 days
Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
PK Parameter: Apparent volume of distribution (Vz/F) of total reactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
PK Parameter: Time at which half the drug has been eliminated (T1/2) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
时间窗: 43 days
PK Parameter: Apparent systemic clearance (CL/F) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
PK Parameter: Area under the concentration-time curve (AUC) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
时间窗: 43 days
Profiles of [14C] BIIB122 ([14C]-DNL151) and its [14C] metabolites in plasma, urine, and feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
时间窗: 43 days
次要结局
- Incidence of adverse events (AEs)(43 days)
- PK Parameter: The ratio of total radioactivity in whole blood to that in plasma following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)(43 days)
- Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces(43 days)