An Open-label Study to Evaluate the Effect of Brodalumab on the Pharmacokinetics of Midazolam and Assess Single-Dose Brodalumab Pharmacokinetics in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab
研究概览
简要总结
This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.
详细描述
Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- •body mass index (BMI) between ≥ 18.0 and ≤ 38.0 kg/m2
- •body weight between ≥ 50 and ≤ 130 kg
- •no known history of active tuberculosis
排除标准
- •Female subjects who are lactating/breastfeeding
- •History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
Brodalumab 140mg SC
open label, all subjects receive brodulamab
干预措施: Brodalumab (Drug)
Midazolam (MDZ) 2mg oral, Brodalumab 210mg SC
MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)
干预措施: Brodalumab (Drug)
结局指标
主要结局
The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab
时间窗: Day 1 to day 9
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30
The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration
时间窗: Day 1 to Day 9
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2
The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)
时间窗: Day 1 to Day 9
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30
次要结局
未报告次要终点