NCT01144936已完成1 期
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of VX-985 in Subjects With Genotype 1 Chronic Hepatitis C
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
- 21
- 试验地点
- 3
- 主要终点
- Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)
研究概览
简要总结
The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are male or females of non-childbearing potential aged 18 to 64 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2)
- •Certain subjects must agree to use acceptable contraceptive methods as specified in protocol
- •Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C
- •Subjects must be in good health and have normal laboratory values as judged by investigator
- •Subjects must not have clinically significant abnormal results for physical examination
排除标准
- •Subjects must not have received approved or experimental HCV therapy
- •Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- •Subjects must not have any known history of other cause of significant liver disease including hepatitis B, drug or alcohol-related cirrhosis, etc
- •Subjects must not be diagnosed with or have suspected hepatocellular carcinoma
- •Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or test capable of detecting cirrhosis within the past 2 years
- •Subjects with a known history or other evidence of severe retinopathy or clinically significant ophthalmological disorder
- •Subjects must not have a history of any illness that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject e.g. history of cardiovascular or central nervous system disease, ongoing psychiatric disorder, poorly controlled diabetes, etc
- •Subject must not have taken any of the prohibited medications within the specified time before study start or take certain medications (including herbal supplements) during the study
- •Subjects must not have a history of drug or alcohol abuse or addiction within 6 months before the start of dosing, or test positive for alcohol or drugs of abuse
- •Subjects must not have donated or had a significant loss of blood within 56 days of the start of dosing, or donated more than 1 unit of plasma within 7 days before the start of dosing
- •Subjects must not consume excessive amounts of caffeine
- •Subjects must not have participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months
- •Subjects who are female and have a positive pregnancy test and/or who are considered to be of childbearing potential or are nursing.
- •Subjects that have a female partner who is pregnant, nursing, or planning to become pregnant during the study or shortly after the study
研究组 & 干预措施
Panel 1: VX-985 Dose 1
Experimental
干预措施: VX-985 or matching placebo (Drug)
Panel 2: VX-985 Dose 2
Experimental
干预措施: VX-985 or matching placebo (Drug)
Panel 3: VX-985 Dose 3
Experimental
干预措施: VX-985 or matching placebo (Drug)
结局指标
主要结局
Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)
时间窗: 10-13 days
次要结局
- Plasma pharmacokinetic parameters of VX-985(10-13 days)
- HCV RNA levels(5-7 months)
研究者
研究点 (3)
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