NCT02370043已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of KQ-791 in Healthy Subjects
Kaneq Bioscience Limited2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels may be studied, in two distinct groups or cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Male or non-childbearing potential female, which includes post-menopausal female (absence of menses for 12 months prior to drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration) or surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration)
- •Body Mass Index (BMI) greater than or equal to (≥) 27.0 and less than or equal to (≤) 35.0 kilogram per square meter (kg/m2)
- •Healthy as defined by:
- •absence of clinically significant illness and surgery within last 4 weeks. Participants vomiting within 24 hours pre-dose will be evaluated for upcoming illness/disease
- •the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- •Male participants who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner (sterile female partners include post-menopausal females and surgically sterile females) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 90 days after the last study drug administration:
- •simultaneous use of a condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks)
- •simultaneous use of a male condom, and for his female partner, a diaphragm with intravaginally applied spermicide
- •Some degree of insulin resistance, as shown by:
- •fasting blood glucose ≥95.4 and ≤126 milligrams per deciliter (mg/dL) (equivalent to 5.3 to 7.0 millimoles per liter (mmol/L), respectively) and
- •fasting triglycerides ≤ 4.0 mmol/L, and/or
- •Low-Density Lipoprotein Cholesterol (LDL-C) ≤ 6.0 mmol/L
- •Capable of consent
- •Non-smoker (no use of tobacco products within the last 3 months)
排除标准
- •Any clinically significant abnormality or abnormal laboratory test results (other than glucose,triglycerides and LDL-C levels described in inclusion criterion)
- •Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
- •Evidence of clinically significant hepatic or renal impairment, including Alanine Aminotransferase (ALT) above 1.5x Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) above 2x ULN, total bilirubin above 2x ULN (total bilirubin accepted up to 2x ULN if direct bilirubin is within normal limits), or Estimated Glomerular Filtration Rate (eGFR) less than (<) 90 milliliters per minute (mL/minute)
- •Positive urine drug screen
- •History of significant allergic reactions (e.g. angioedema) to any drug.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within the last 30 days
- •Positive pregnancy test
- •Any reason which, in the opinion of the qualified investigator (QI) would prevent the subject from participating in the study
- •Clinically significant electrocardiogram (ECG) abnormalities at screening, or clinically significant personal or family history (in a first-degree relative) of heart diseases, including:
- •Confirmed corrected QT (QTcF) interval greater than (>) 450 milliseconds (msec) for men and women
- •Bundle branch blocks and other conduction abnormalities other than mild first degree atrio-ventricular block
- •Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
- •History of unexplained syncope
- •Family history of unexplained sudden death or sudden death due to long QT syndrome
- •T-wave configurations are not of sufficient quality for assessing QT interval
- •Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 150 mmHg, diastolic blood pressure lower than 50 or over 95 mmHg, or heart rate less than 50 or over 100 beats per minute (bpm))
- •History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening (regular use of more than three units of alcohol per day for males and more than two units of alcohol per day for females [1 unit = 150 (milliliter) mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test
- •History of significant drug abuse within the last year or use of soft drugs (such as marijuana) within 3 months prior, or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within the last year
- •Participation in a clinical trial involving the administration of an investigational or marketed drug within the last 30 days (90 days for biologics) or concomitant participation in an investigational study
- •Use of medication other than topical products without significant systemic absorption:
- •prescription medication within last 14 days
- •over-the-counter products within the last 7 days, with the exception of the occasional use of acetaminophen (up to 2 grams (g) daily)
- •natural health products (e.g. food supplements or herbal supplements) within last 14 days
- •a depot injection or an implant of any drug within last 3 months
- •Donation of plasma within the last 7 days. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days
- •Hemoglobin <128 grams per liter (g/L) (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females)
- •Breast-feeding participant
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose of placebo matching KQ-791 dose
干预措施: Placebo (Drug)
KQ-791
Experimental
Escalating doses of KQ-791, starting at 15 milligrams
干预措施: KQ-791 (Drug)
KQ-791 (after meal)
Experimental
Single dose of KQ-791 in capsule form, after a meal
干预措施: KQ-791 (after meal) (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: Baseline to study completion (up to 11 weeks)
次要结局
- Area Under the Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose)
- Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg')
- Maximum Observed Drug Concentration (Cmax)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Residual Area(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Time to Observed Cmax (Tmax)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels)
- Elimination Half-Life (T1/2 el)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Elimination Rate Constant (Kel)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Apparent Body Clearance (Cl/F)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Apparent Volume of Distribution (Vd/F)(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) in Fed Versus Fasting State(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Area Under the Concentration-time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) in Fed Versus Fasting State(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Maximum Observed Drug Concentration (Cmax) in Fed Versus Fasting State(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg)
- Time to Maximum Drug Concentration (Tmax) in Fed Versus Fasting State(Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels)
- Amount of Drug Excreted in Urine(Four hour intervals up to 12 hours, and then 12-24 hours post dose)
- Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t)(Four hour intervals up to 12 hours, and then 12-24 hours post dose)
- Maximum Rate of Urinary Excretion (Rmax)(Four hour intervals up to 12 hours, and then 12-24 hours post dose)
- Time of Rmax Urinary Excretion (TRmax)(Four hour intervals up to 12 hours, and then 12-24 hours post dose)
- Renal Clearance (Clr)(Four hour intervals up to 12 hours, and then 12-24 hours post dose)
研究者
研究点 (2)
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