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临床试验/NCT02015715
NCT02015715已完成1 期

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6864018 Following Oral Administration in Asian Healthy Subjects

Hoffmann-La Roche1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年12月最近更新:
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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
48
试验地点
1
主要终点
Number of Participants With Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to receive a single oral administration of RO6864018 or placebo. Total study duration for each participant is up to 9 weeks.

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
21 Years 至 65 Years（Adult, Older Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian
  • •No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • •Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds [lb]) inclusive at screening
  • •Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day

排除标准

  • •History or symptoms of any significant disease
  • •Personal or family history of congenital long QT syndrome or sudden death
  • •Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
  • •Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
  • •Suspicion of regular consumption of drug of abuse
  • •History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol)
  • •Participants who have received Interferon (IFN) or peginterferon within 8 weeks prior to dosing
  • •Use of any medication (prescription or over the counter [OTC], including health supplements and herbal remedies) within 2 weeks before the first dose of study medication
  • •Positive Hepatitis A immunoglobulin M antibody (HAV IgM Ab), Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening
  • •Donation or loss of blood of greater than 500 milliliters (mL) within 90 days prior to dosing
  • •Have participated in other clinical studies within 60 days prior to study randomization

研究组 & 干预措施

Placebo

Placebo Comparator

Participants will receive a single oral dose of placebo matching to RO6864018.

干预措施: Placebo (Drug)

RO6864018

Experimental

Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1.

干预措施: RO6864018 (Drug)

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: Baseline up to Day 29

次要结局

  • AUClast of Active Metabolite RO6871765(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6864018(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • AUC0-inf of Active Metabolite RO6871765(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • AUClast of Prodrug Metabolite RO6870868(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • AUC0-inf of Prodrug Metabolite RO6870868(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • AUC0-inf of Minor Metabolite RO6872373(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO6864018(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • AUClast of Minor Metabolite RO6872373(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Maximum Observed Plasma Concentration (Cmax) of RO6864018(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Cmax of Active Metabolite RO6871765(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Cmax of Prodrug Metabolite RO6870868(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Cmax of Minor Metabolite RO6872373(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Time to Maximum Plasma Concentration (Tmax) of RO6864018(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Tmax of Active Metabolite RO6871765(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Tmax of Minor Metabolite RO6872373(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • RO6864018 Urine Concentration(Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose)
  • Active Metabolite RO6871765 Urine Concentration(Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose)
  • Prodrug Metabolite RO6870868 Urine Concentration(Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose)
  • Minor Metabolite RO6872373 Urine Concentration(Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose)
  • Apparent Terminal Elimination Half-Life (T1/2) of RO6864018(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • T1/2 of Active Metabolite RO6871765(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Myxovirus Resistance 1 (MX-1) Gene mRNA Levels in Whole Blood(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • T1/2 of Prodrug Metabolite RO6870868(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • T1/2 of Minor Metabolite RO6872373(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Serum Interferon alpha Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum Interferon-Gamma-Inducible Protein-10 (IP-10) Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum Interleukin (IL)-6 Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum IL-10 Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum IL-12 Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum Neopterin Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Serum p40 (IL-12B) Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Interferon-Stimulated Gene-15 (ISG-15) Messenger Ribonucleic Acid (mRNA) Levels in Whole Blood(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Oligoadenylate Synthetase 1 (OAS 1) Gene mRNA Levels in Whole Blood(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Toll-Like Receptor 7 (TLR7) Gene mRNA Levels in Whole Blood(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)
  • Tmax of Prodrug Metabolite RO6870868(Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose)
  • Serum Tumor Necrosis Factor Alpha Levels(Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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