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临床试验/NCT02470286
NCT02470286已完成1 期

A Phase1, Double-blind, Randomized, Placebo-control, Single Center, Single Dose Administration, Dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of SA001 in Healthy Male Volunteers.

Samjin Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年6月29日最近更新:
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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
40
试验地点
1
主要终点
The incidence of treated related adverse event
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

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

详细描述

This study consists of Part 1 followed Part 2.

Part 1 (Dose escalation study, SA001 60mg~300mg dose group) The part 1 is a dose escalation study. The starting dose is SA001 60mg, and the maximum dose is 300mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration on the fasting state.

Part 2 (Single dose and food effect study, SA001 120mg and 300mg dose group) The purpose of this part 2 is to evaluate the food effect of a high-fat diets(HFDs) on the single oral dose pharmacokinetics of SA001 and its metabolite.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •19 years to 45 years (Healthy male Korean)
  • •Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m^2
  • •Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study

排除标准

  • •Subject with a disease history of any clinically significant condition as below.
  • •Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
  • •Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug
  • •Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
  • •Serum ALT(SGPT)/AST(SGOT) >1.5×institutional upper limit normal (ULN)
  • •eGFR< 90mL/min/1.73m^2
  • •Systolic blood pressure <100 mmHg or >160 mmHg
  • •Diastolic blood pressure <60 mmHg or >100 mmHg
  • •Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:
  • •QTcF > 430msec (males)
  • •PR interval > 200msec or < 110msec
  • •QRS complex > 120msec
  • •Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
  • •Pathologic Q waves (defined as Q-wave > 40msec or depth > 0.5mV)
  • •Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)
  • •Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias
  • •Subject with a history of drug abuse within 60 days prior to screening or who is positive for drugs of abuse in urine tests at screening
  • •Subject who received any prescription drug or herbal medicine within 14 days prior to the first administration of the Investigational product
  • •Subject who received any drugs such as
  • •Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
  • •Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
  • •Subject who received other investigational products within 90 days prior to the first administration of the investigational products
  • •Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
  • •Subject with history of smoking within 90 days prior to the first administration of the investigational products
  • •Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products
  • •Man of reproductive potential not willing to use contraceptive measures during the study period
  • •Subject not eligible for study participation in the opinion of the investigator

研究组 & 干预措施

Cohort 2 (SA001 120mg or Placebo)

Experimental

6 subjects receiving a single dose of 120mg SA001 and 2 subjects receiving placebo

干预措施: SA001 120mg or Placebo (Drug)

Cohort 1 (SA001 60mg or Placebo)

Experimental

6 subjects receiving a single dose of 60mg SA001 and 2 subjects receiving placebo

干预措施: SA001 60mg or Placebo (Drug)

Cohort 3 (SA001 180mg or Placebo)

Experimental

6 subjects receiving a single dose of 180mg SA001 and 2 subjects receiving placebo

干预措施: SA001 180mg or Placebo (Drug)

Cohort 4 (SA001 240mg or Placebo)

Experimental

6 subjects receiving a single dose of 240mg SA001 and 2 subjects receiving placebo

干预措施: SA001 240mg or Placebo (Drug)

Cohort 5 (SA001 300mg or Placebo)

Experimental

6 subjects receiving a single dose of 300mg SA001 and 2 subjects receiving placebo

干预措施: SA001 300mg or Placebo (Drug)

结局指标

主要结局

The incidence of treated related adverse event

时间窗: Part1: Day-2(administration) to approximately Day 15 (Post study visit)

Safety/Tolerability Assessment in the part 1

次要结局

  • Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞) of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • Maximum observed plasma concentration (Cmax) of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • Fraction recovered unchanged in urine (FR) of SA001 and its metabolite(Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose)
  • CLR of SA001 and its metabolite(Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose)
  • Time to reach the maximum observed plasma concentration (tmax) of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • t1/2 of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • Vz/F of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)
  • CL/F of SA001 and its metabolite(Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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