A Three-Part, Phase I Study Of Orally Administered GRC 27864, A Novel, Microsomal Prostaglandin E Synthase-1 Enzyme (mPGES-1) Inhibitor, To Evaluate The Safety, Tolerability And PK Of Single Ascending Doses In Healthy, Adult Subjects (Part 1a), And Of A Single Dose In Elderly Subjects (Part 2); The Effect Of Food On PK (Part 1b) In Healthy, Adult Subjects; And To Compare The Effects On Prostanoid Metabolism With Celecoxib (Part 3) In Healthy, Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Drug related adverse events (AEs) or any serious AEs
研究概览
简要总结
A Single Dose Study of GRC 27864 in Healthy Volunteers.
详细描述
This is a phase I study of GRC 27864 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy subjects, age ≥18 to ≤55 years (≥65 years for elderly subjects study) at the time of informed consent
- •Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m2), inclusive
- •Female subjects who are of child-bearing potential or had tubal ligation must agree to use highly effective methods of contraception
- •Male subjects whose partners are of child-bearing potential or had tubal ligation must also agree to use two highly effective method of contraception
排除标准
- •Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation.
- •Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the clinical study, expose the subject to undue risk.
- •Veins unsuitable for repeat venepuncture.
- •Presence of clinical laboratory test values judged clinically significant by the investigator.
- •Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV)-1 and/or -2 antibodies at screening.
- •History or presence of drug abuse at screening or upon admission to the CRU.
- •Participation in another clinical study with an experimental drug within 3 months before the first administration of the IMP.
- •Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the subject to comply with the Clinical Study Protocol requirements.
研究组 & 干预措施
GRC 27864
Test Treatment GRC 27864
干预措施: GRC 27864 (Drug)
Celecoxib
Active Comparator Treatment
干预措施: Celecoxib (Drug)
Placebo
Placebo Treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Drug related adverse events (AEs) or any serious AEs
时间窗: 15 days after administration of the study drug
All treatment-emergent adverse events (TEAE) occurring in the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events, in adult healthy volunteers from baseline to day 15.
次要结局
- Maximum Concentration (Cmax) of GRC 27864(Post dose up to 72 hours)
- Time to Maximum Concentration (Tmax) of GRC 27864(Pre-dose to and post-dose from 15 minutes to 72 hours)
- Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864(Pre-dose to and post-dose from 15 minutes to 72 hours)