NCT01080820已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of CMX157 in Healthy Adult Volunteers.
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
- Chimerix
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and the time that it takes to eliminate CMX157 following one oral dose when given to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, 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
- •Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study.
排除标准
- •Currently nursing females, pregnant females, or females of child-bearing potential.
- •Hypersensitivity to tenofovir.
- •Use of any antiviral, corticosteroid, immunosuppressive, or anticoagulant prescription drug within 4 weeks prior to enrollment. Use of any other prescription drug within 14 days prior to enrollment.
- •Use of any over-the-counter medication, herbal/nutraceutical preparation, within 7 days prior to enrollment.
- •Administration of any potentially nephrotoxic drug within 14 days prior to enrollment.
- •Use of an investigational drug and/or treatment within 30 days prior to enrollment.
- •Use of illicit drugs within 6 months prior to screening and enrollment, based on history and a urine drug screen.
- •Infection with HIV, HBV or HCV.
- •History of abuse of alcohol or other substance (s) within 6 months prior to enrollment.
- •History or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, cardiomyopathy, and cardiac conduction disorders.
- •History of clinically significant hypotension (including orthostatic), fainting, or lightheadedness.
- •History of gastrointestinal disease or impairment.
- •History of renal impairment or disorder.
- •History of liver disease or impairment.
- •History of cancer, except basal cell carcinoma.
- •History of pathologic bone fractures; history or risk of osteopenia
- •History of diabetes, metabolic disease, or autoimmune disease; history of immunodeficiency in healthy volunteers.
- •Acute illness or fever 38 C within 1 week prior to enrollment.
- •Supine blood pressure - systolic outside the range of 90-140 mmHg, or diastolic outside the range of 50-90 mmHg.
- •Resting heart rate > 100 or < 45 beats per minute.
- •Body Mass Index (BMI) >31 or <18, or body weight <50 kg for men and < 45 kg for women.
- •Whole blood donation within 56 days or plasma donation within 30 days prior to enrollment.
研究组 & 干预措施
Placebo + Viread
Placebo Comparator
干预措施: Placebo (Drug)
Placebo + Viread
Placebo Comparator
干预措施: Viread (Drug)
Viread
Active Comparator
干预措施: Viread (Drug)
CMX157 + Viread
Experimental
干预措施: CMX157 (Drug)
CMX157 + Viread
Experimental
干预措施: Viread (Drug)
结局指标
主要结局
Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram
时间窗: dosing-28 days post-dose
次要结局
- CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration.(dosin - 28 days post-dose)
研究者
研究点 (1)
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