NCT01911637已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Sequential, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of VBY-036 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
- 发起方
- Virobay Inc.
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Highest safe and tolerated VBY-036 dose
研究概览
简要总结
VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).
详细描述
Detailed description is noted in Brief Summary.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female, 18-60 years old
- •Screening body mass index between 18-32 kg/m2
- •Good health, no clinically significant findings in medical history, 12-lead ECG, & vital signs;
- •Clinical lab evaluations (Chem panel [fasted at least 8 hrs], CBC, HbA1c & UA in reference range for test lab (unless deemed not clinically significant);
- •Negative test for drugs of abuse at Screening & at Check-in (includes alcohol);
- •Negative hepatitis, HIV & TB screens;
- •Females non-pregnant, non-lactating, & either postmenopausal for at least 1 year, surgically sterile for at least 90 days prior to Check-in, or agree to use from the time of consent until 90 days after Study Completion an effective form of contraception. For all females, a pregnancy test result must be negative at Screening & Check-in.
- •Males will be sterile or agree to use from Check-in until 90 days following discharge an effective method of contraception.
- •Able to comprehend & willing to sign Informed Consent Form
排除标准
- •Females pregnant or nursing, or childbearing potential but unwilling to use contraception.
- •History of renal or hepatic impairment; stomach or intestinal surgery or resection, malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would alter absorption &/or excretion of orally administered drugs (appendectomy or hernia repair allowed);
- •Anemia (hemoglobin <11.5 g/dL for females; < 13 g/dL for males) or blood donation within 8 weeks of Check-in;
- •Plasma donation within 4 weeks of Check-in;
- •History of alcoholism or drug addiction within 6 months to Check-in;
- •Use of drugs of abuse or prescription drugs for recreational use 6 months prior to Check-in;
- •Use of any tobacco-containing or nicotine-containing products 6 months prior to Check-in & during study;
- •Participation in another drug trial 30 days of Check-in (within 8 weeks if previous investigational drug has immunomodulary effects, other than cathepsin S inhibition);
- •History or clinical manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
- •History of hypersensitivity or allergies to any drug compound
- •History or presence of abnormal ECG
- •Laboratory abnormality deemed clinically significant;
- •Use of or inability to discontinue any prescription medications/products 14 days prior to Check-in & during study;
- •Use of certain over-the-counter, non-prescription preparations are permitted up to 3 days before first dose;
- •Use of alcohol-containing, grapefruit-containing, star fruit containing foods or beverages or "energy drinks" 72 hours to Check-in & during study;
- •Poor peripheral venous access;
- •Receipt of blood products 6 months to Check-in
- •Subjects with history of Gilbert's Syndrome;
- •Strenuous activities 48 hours before receiving experimental or placebo comparator
- •Illness 5 days to drug administration
- •Any acute or chronic condition
研究组 & 干预措施
VBY-036
Experimental
VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg
干预措施: VBY-036 (Drug)
VBY-036
Experimental
VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: VBY-036 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Highest safe and tolerated VBY-036 dose
时间窗: 5-days assessment
Single dose of VBY-036 given one day for each cohort in an ascending manner. Cohort A1 with 10 mg dose or placebo; Cohort A2 with 30 mg dose or placebo; Cohort A3 with 100 mg dose or placebo; Cohort A4 with 300 mg dose or placebo; Cohort A5 with 600 mg dose or placebo; Cohort A6 with 900 mg dose or placebo
次要结局
- Confirmation of cathepsin-S inhibition(2 days)
研究者
研究点 (1)
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