A Phase 1, Open-Label, Crossover Study to Assess the Potential for Gastric pH-Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of BIIB122
研究概览
简要总结
The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18 and 30 kilograms per square meter (kg/^m2), inclusive.
- •Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.
- •For participants ≥ 55 years of age, ongoing conditions must be considered by the Investigator to be stable and adequately controlled by allowed concomitant medications.
排除标准
- •Plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the follow-up visit.
- •Any condition affecting study treatment absorption.
- •History of gastrointestinal surgery, gastroesophageal reflux disease, or other clinically significant and active gastrointestinal condition per the Investigator's discretion.
- •Clinically significant acute gastrointestinal symptoms within 30 days prior to study Check-in (Day -1).
- •Chronic, recurrent, or serious infection, as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -
- •For participants < 55 years of age: Use of any prescription medication (excluding oral contraceptives and hormone replacement therapy), OTC oral medications including proton pump inhibitors (PPI), histamine H2-receptor antagonists (H2 blockers), and antacids (excluding acetaminophen and aspirin ≤ 100 mg daily), or nutraceuticals including vitamins/mineral supplements/herbal medicines within 28 days prior to Day -1 and throughout the study.
- •For participants ≥ 55 years of age: Up to 5 medications are allowed if they are taken at a stable dose level and regimen.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Period 1
Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period.
干预措施: BIIB122 (Drug)
Period 2
Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
干预措施: BIIB122 (Drug)
Period 2
Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
干预措施: Rabeprazole (Drug)
Period 3
Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.
干预措施: BIIB122 (Drug)
Period 3
Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of BIIB122
时间窗: Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122
时间窗: Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122
时间窗: Up to Day 55
次要结局
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 55)