A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
详细描述
The first phase assesses single ascending doses for EDP 305 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses (active drug or placebo) for 14-days in healthy subjects and also in subjects with presumptive NAFLD (i.e., obese subjects with or without prediabetes or T2DM).
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-305 or placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- •Clinically relevant evidence or history of illness or disease.
- •Pregnant or nursing females.
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •A positive urine drug screen at screening or Day -
- •Current tobacco smokers or use of tobacco within 3 months prior to screening.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- •History of regular alcohol consumption
- •Participation in a clinical trial within 30 days prior to study drug administration.
- •Use of prescription drugs, non-prescription drugs, dietary supplements including Vitamin E herbal supplements, hormonal therapy/replacement or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study medication.
- •Additional Exclusion Criteria for MAD Subjects with Presumptive NAFLD:
- •Subjects taking any antidiabetic medication.
- •Subjects with unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).
- •Subject has taken fibrates, statins, and/or Vitamin E within 6 weeks prior to the first dose administration.
- •Subjects with a history of bariatric surgery and any other gastrointestinal surgery relative to weight loss.
- •Subjects with common causes of secondary hepatic steatosis.
研究组 & 干预措施
EDP 305 SAD Cohorts
EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration
干预措施: EDP 305 (Drug)
EDP 305 MAD Cohorts
EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days
干预措施: EDP 305 (Drug)
EDP 305 SAD Placebo Cohort
Matching placebo, oral suspension, once daily in one single administration
干预措施: Placebo (Drug)
EDP 305 MAD Placebo Cohort
Matching placebo, oral suspension, once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety data including but not limited to adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis).
时间窗: From screening to the 7-day post treatment safety follow up visit.
次要结局
- AUC(Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose)
- Cmax(Day 1: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15 hrs; Days 2, 3, 4, 5, 7, 9, 12; Day 14: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24 (D15), 30, 36, 48 (D16), 60, 72 (D17), and 96 (D18) hrs postdose)