A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Number of subjects reporting an adverse event or experiencing a laboratory abnormality
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Chronically infected with HCV genotype 1
- •HCV treatment-naïve
- •Not co-infected with HIV or HBV
- •HCV RNA viral load of at least 100,000 IU/mL
- •BMI 19 to 35 kg/m2
- •Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
排除标准
- •History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- •Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
- •Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- •Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse
研究组 & 干预措施
Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
干预措施: GS-5885 (Drug)
Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects reporting an adverse event or experiencing a laboratory abnormality
时间窗: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
时间窗: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
次要结局
- Measure of GS-5885 plasma concentration over time(Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days)
- Emergence of viral resistance(Up to 48 weeks following Study Day 14)