NCT01930058已完成1 期
A Multiple Dose Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MK-8876 in Hepatitis C Patients
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
- 9
- 主要终点
- Mean Change From Baseline in HCV Viral Load
研究概览
简要总结
This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection. The study will consist of 4 parts evaluating participants infected with specific hepatitis C virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. The hypothesis evaluated in the study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple dose administration of MK-8876 in participants with HCV infection.
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
- None
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
- •is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation)
- •agrees to use a medically acceptable method of contraception through 90 days after the last dose of study drug if participant has a female partner of childbearing potential must (males should use a condom and their partner of childbearing potential must use hormonal contraception, intrauterine device, diaphragm, cervical cap, or female condom)
- •has a body mass index (BMI) between 18 and 37 kg/m^2
- •has a clinical diagnosis of chronic HCV infection defined by positive serology for HCV for ≥6 months
- •agrees to follow the smoking and other trial restrictions
排除标准
- •is mentally or legally institutionalized or incapacitated, has significant emotional problems at study start or has clinically significant psychiatric disorder of the last 5 years
- •has a history of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •has a history of stroke, chronic seizures, or major neurological disorder
- •has a history of cancer (except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of the cervix, or other malignancies which have been successfully treated for ≥10 years
- •has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to drugs or food
- •has a history of clinically significant hepatic disease, Gilbert's disease, biliary tract disease, or human immunodeficiency virus
- •has had major surgery or donated or lost >1 unit of blood within 4 weeks before the study
- •has participated in another investigational trial within 4 weeks before the study
- •Is unable to refrain from or anticipates the use of any medication from 2 weeks before the study and throughout the study
- •consumes >2 glasses of alcoholic beverages per day
- •consumes >6 servings (1 serving is ~120 mg caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
- •is a regular user of any illicit drugs or history of drug abuse within 12 months of the study
- •has evidence or history of chronic hepatitis not caused by HCV (except acute non-HCV-related hepatitis that resolved >6 months before the study)
- •has previously received treatment with another HCV non-nucleoside inhibitor (previous use of other HCV investigational therapies or marketed compounds is permitted if treatment ended ≥3 months before the study)
- •has clinical or laboratory evidence of advanced or decompensated liver disease
研究组 & 干预措施
Panel A: HCV GT3 MK-8876 150 mg
Experimental
Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
干预措施: MK-8876 (Drug)
Panel B: HCV GT3 MK-8876 800 mg
Experimental
Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
干预措施: MK-8876 (Drug)
Panel E: HCV GT1a MK-8876 800 mg
Experimental
Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
干预措施: MK-8876 (Drug)
结局指标
主要结局
Mean Change From Baseline in HCV Viral Load
时间窗: Baseline and Day 7
The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.
次要结局
- Maximum Plasma Concentration (Cmax) of MK-8876(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7)
- Time to Maximum Plasma Concentration (Tmax) of MK-8876(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7)
- Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7)
- Trough Plasma Concentration (C24hr) of MK-8876(24 hours post-dose on Days 1 and 7)
- Apparent Terminal Plasma Half-life (t½) of MK-8876(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7)
研究者
相似试验
已完成
1 期
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)Hepatitis CNCT02269059Merck Sharp & Dohme LLC13
已完成
1 期
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)Hepatitis CNCT02161510Merck Sharp & Dohme LLC13
已完成
2 期
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an OptionHepatitis CLiver DiseaseNCT02094443Debiopharm International SA52
已完成
1 期
Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)Hepatitis C InfectionNCT02076100Merck Sharp & Dohme LLC22
已完成
2 期
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIVHIVHepatitis CNCT01878799National Institute of Allergy and Infectious Diseases (NIAID)50