NCT05127564已完成1 期
An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (BIIB098) in Chinese and Caucasian Adult Healthy Participants
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
- 32
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of Monomethyl Fumarate (MMF)
研究概览
简要总结
The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2), inclusive.
- •Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening and Day -
- •For Chinese participants: was born in China, and biological parents and grandparents were of Chinese origin. If living outside China for more than 5 years, must not have had a significantly modified diet since leaving China.
排除标准
- •History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the investigator, are likely to be exacerbated by any component of the study treatment; or systemic hypersensitivity reactions to DRF, dimethyl fumarate (DMF), MMF, other fumaric esters, excipients in the formulation, or diagnostic agents to be administered during the study.
- •Confirmed demonstration of corrected QT interval, using Fridericia's correction method, of >450 milliseconds (ms) for males and >460 ms for females.
- •Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant and active GI condition, per the investigator's discretion.
- •Has experienced clinically significant acute GI symptoms in the judgment of the investigator within 30 days prior to admission.
- •History or positive test result at screening for human immunodeficiency virus (HIV).
- •Chronic, recurrent, or serious infection, as determined by the investigator, within 90 days prior to screening and between screening and Day -
- •Current enrollment in any other drug, biological, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
- •Previous participation in this study or previous studies with DRF or DMF.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
DRF: Chinese Participants
Experimental
Chinese participants will receive DRF Dose 1, oral capsules, twice daily (BID), from Day 1 to Day 4 and DRF Dose 1, oral capsules, once daily (QD), on Day 5.
干预措施: Diroximel fumarate (Drug)
DRF: Caucasian Participants
Experimental
Caucasian participants will receive DRF Dose 1, oral capsules, BID, from Day 1 to Day 4 and DRF Dose 1, oral capsules, QD, on Day 5.
干预措施: Diroximel fumarate (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of Monomethyl Fumarate (MMF)
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
Area Under the Concentration-Time Curve within a Dosing Interval (AUCtau) of MMF
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8
次要结局
- Apparent Volume of Distribution (Vz/F) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Time to Reach Maximum Observed Concentration (Tmax) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Lag Time in Absorption (Tlag) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Apparent Total Body Clearance (CL/F) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Accumulation Ratio Following Multiple Dosing (Rac) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Maximum Observed Concentration (Cmax) of 2-Hydroxyethyl Succinimide (HES)(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Apparent Total Body Clearance (CL/F) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Elimination Half-Life (t½) of MMF(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Time to Reach Maximum Observed Concentration (Tmax) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Lag Time in Absorption (Tlag) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Area Under the Concentration-Time Curve within a Dosing Interval (AUCtau) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Elimination Half-Life (t½) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Apparent Volume of Distribution (Vz/F) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Accumulation Ratio Following Multiple Dosing (Rac) of HES(Pre-dose and at multiple timepoints post-dose on Days 1 and 5 and post-dose on Days 6, 7 and 8)
- Number of Participants with Adverse Events (AEs)(Day 1 to Day 10)
- Number of Participants with Serious Adverse Events (SAEs)(Screening to Day 10)
研究者
研究点 (1)
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