NCT03880487终止1 期
A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events
研究概览
简要总结
This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult 18-45 years of age at time of screening, inclusive.
- •Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
- •Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
- •For both male and females: using acceptable method of birth control
- •If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
- •All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research site. An exception is made for hormonal contraceptives, which may be used throughout the study.
- •All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research site.
- •Must be adequately informed and understand the nature and risks of the study and must provide written informed consent prior to enrollment at screening.
排除标准
- •Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
- •Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- •Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- •History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
- •Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission > 450 ms.
- •Positive screening test for hepatitis B surface antigen, anti-hepatitis C virus antibodies or anti-human immunodeficiency virus 1 and 2 antibodies.
- •History of drug allergy diagnosed by a physician.
- •Use of tobacco within 30 days prior to the first study drug administration.
- •History of alcohol consumption exceeding 2 standard drinks per day on average.
- •Routine or chronic use of more than 0.5 grams of acetaminophen daily.
- •History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research site or planned donation before 30 days has elapsed since intake of study drug.
- •Plasma or platelet donation within 7 days of dosing
- •Use of any investigational drug or device within 30 days of the first dose of study.
研究组 & 干预措施
KP-1199
Experimental
干预措施: KP-1199 (Drug)
Placebo oral capsules
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
Oxycodone oral capsules
Active Comparator
干预措施: Oxycodone oral capsule (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events
时间窗: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12
Number of treatment related adverse events as determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters
次要结局
- Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199(Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7))
- Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199(Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7))
- Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199(Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7))
- Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199(Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7))
- Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199(Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7))
- Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold(Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration))
- Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance(Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration))
- Pharmacodynamic Effects of KP-1199 using Cold Pressor Test(Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration))
- Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB)(Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration))
研究者
研究点 (1)
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