A Randomized, Double-Blind, Placebo-Controlled, Ascending One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The primary objective of the study is to determine the safety of single doses of orally administered EDP-788.
Secondary objectives of the study are:
- To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single doses of orally administered drug
- To estimate the bioavailability of EDP-788 capsules relative to an oral liquid suspension
- To estimate the effect of co-administration of food on the absorption of EDP-788
详细描述
Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or placebo capsules. If the safety profile of the drug is acceptable, based upon review of blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).
Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first dose. The second dose will be administered as a liquid suspension rather than as a capsule formulation. The purpose of the second dose is to estimate the bioavailability of the capsule formulation relative to the suspension.
Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first does. The second dose will be administered with a standard test meal. The purpose of the second dose is to estimate the effect of food on absorption of EDP-788.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health
- •BMI between 18 - 32 kg/m2
- •Women must be of non-childbearing potential (surgically sterilized)
- •Normal electrocardiogram
- •Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 8 - 10 day post-dosing visit
排除标准
- •Hypersensitivity to macrolide antibiotics
- •Abnormal laboratory values
- •History of gastrointestinal surgery which may interfere with drug absorption
- •Active Hepatitis B, Hepatitis C, or HIV infection
- •Use of prescription or non-prescription drugs within 14 days of study drug administration
- •Use of nicotine within 3 months of study drug administration
研究组 & 干预措施
EDP-788
Single doses with dose escalation to continue in successive cohorts
干预措施: EDP-788 (Drug)
Placebo
Single dose with matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: From time of dosing to 8 - 10 days after receiving study drug
次要结局
- Changes from baseline in laboratory values and vital signs(From time of dosing to 8 - 10 days after receiving study drug)