NCT01485146已完成1 期
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
研究概览
简要总结
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
- •Body Mass Index of 18-32 kg/m2 inclusive with body weight >50 kg
排除标准
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2 x Upper Limit of Normal(ULN), serum creatinine >ULN, Hemoglobin <12.0 g/dL
- •Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- •History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
- •Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization
- •Other exclusion criteria apply
研究组 & 干预措施
Cohort 1
Experimental
8 Healthy Subjects in Phase I Unit
干预措施: ETC-1002 (Drug)
Cohort 2
Experimental
8 Healthy Subjects in Phase I Unit
干预措施: ETC-1002 (Drug)
Cohort 3
Experimental
8 Healthy Subjects in Phase I Unit
干预措施: ETC-1002 (Drug)
结局指标
主要结局
Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
时间窗: 14 days
次要结局
- Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild DyslipidemiaMild DyslipidemiaNCT01105598Esperion Therapeutics, Inc.53
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy VolunteersArthritis, RheumatoidNCT03315494Oscotec Inc.24
Unknown
1 期
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy SubjectsHuman Immunodeficiency Virus-1 (HIV-1) InfectionNCT05328583RetroLead (Shanghai) BioPharma Co., Ltd.64
已完成
1 期
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy SubjectsHealthyNCT06350279Haisco Pharmaceutical Group Co., Ltd.96
已完成
1 期
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With SchizophreniaSchizophreniaNCT01457339Shire31