A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
研究概览
简要总结
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
详细描述
Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females.
- •Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- •Body Mass Index within 18.0 - 34.0 kg/m2, inclusive
排除标准
- •Known history or presence of any clinically significant hepatic, renal/genitourinary, Gastrointestinal (GI), cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- •Clinically significant history or presence of any clinically significant GI pathology unresolved GI symptoms, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- •Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- •Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator.
- •Lymphocyte count <1.5x 10^9/L.
- •Known history or presence of: Alcohol abuse or dependence within one year prior to first study drug administration; Drug abuse or dependence; Hypersensitivity or idiosyncratic reaction to DMF, its excipients, and/or related substances; Progressive multifocal leukoencephalopathy (PML); Fanconi syndrome; Flushing (e.g., warmth, redness, itching, and burning sensation); Low white blood cell count (lymphopenia);
研究组 & 干预措施
Bafiertam
oral capsules administered twice daily
干预措施: Bafiertam (Drug)
Tecfidera
oral capsules administered twice daily
干预措施: Tecfidera (Drug)
结局指标
主要结局
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period.
时间窗: 5 weeks
The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
次要结局
- Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score(5 weeks)
- The number of days that a subject experiences at least one GI symptom.(5 weeks)
- AUC in the MOGISS total score within in each subject over the treatment period(5 weeks)
- Frequency, severity, and duration of overall GI events using the MOGISS.(5 weeks)
- Safety and tolerability outcomes: incidence rates of all non GI-adverse events(5 weeks)