NCT00870441终止1 期
A Phase 1, Randomized, Double-Blind, Multiple Dose, Multi-Center Study to Compare the Safety of ASP2151 to Valacylcovir and Placebo in Healthy Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 442
- 主要终点
- Assessment of clinical laboratory evaluations and adverse events
研究概览
简要总结
The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-35 kg/m2, inclusive
- •If female, subject is using a medically acceptable contraceptive method along with a double-barrier method to prevent pregnancy and agrees to continue using this method throughout study; and is not lactating or pregnant as documented by a negative serum pregnancy test
- •The subject is medically healthy, with a normal 12-lead electrocardiogram (ECG)
排除标准
- •History of any clinically significant disease or malignancy excluding non-melanoma skin cancer
- •History of liver disease, liver dysfunction, liver enzyme elevations, or Gilbert's disease
- •History of acute or chronic pancreatitis or pancreatic insufficiency
- •History of gout, hyperuricemia, or crystalluria
- •History of chronic pain requiring medical therapy
- •Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- •Positive test for human immunodeficiency virus (HIV) antibody
- •Clinical laboratory tests outside the normal limits and considered by the investigator to be clinically significant
- •The subject has difficulty swallowing tablets
- •Clinically significant illness within one month prior to study drug administration
- •History of drug or alcohol abuse within 2 years prior to study drug administration
- •Treatment with prescription medication (with the exception of contraceptives and hormone replacement therapy (HRT)) or complementary and alternative medicines (CAM) within 14 days; over-the-counter products with exception of ibuprofen within 14 days; or alcohol, grapefruit or grapefruit juice containing beverage within 72 hours
- •Donated blood or has had significant blood loss within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
研究组 & 干预措施
1. ASP2151
Experimental
干预措施: ASP2151 (Drug)
2. Valacyclovir
Active Comparator
干预措施: Valacyclovir (Drug)
3. Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of clinical laboratory evaluations and adverse events
时间窗: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit
次要结局
- Assessment of ECG, vital signs and physical examination(Days 1,4,7,10,14,17,21,24 and 28)
研究者
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