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

Kalyra Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 26 人2019年3月12日

适应症Analgesia

干预措施KP-1199 Placebo oral capsule Oxycodone oral capsule

概览

阶段: 1 期
干预措施: KP-1199
疾病 / 适应症: Analgesia
发起方: Kalyra Pharmaceuticals, Inc.
入组人数: 26
试验地点: 1
主要终点: Number of Participants with Treatment Emergent Adverse Events
状态: 终止
最后更新: 4年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2019年3月12日

结束日期

2020年4月21日

最后更新

4年前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

Kalyra Pharmaceuticals, Inc.

责任方

Sponsor

入排标准

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.

研究组 & 干预措施

KP-1199

干预措施: KP-1199

Placebo oral capsules

干预措施: Placebo oral capsule

Oxycodone oral capsules

干预措施: Oxycodone oral capsule

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))