NCT02361034已完成1 期
A Two-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 Pharmacokinetics of Multiple Ascending Doses in Healthy Subjects (Part 1), and of Multiple Doses in Elderly Subjects (Part 2)
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
- 32
- 试验地点
- 1
- 主要终点
- Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects
研究概览
简要总结
This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.
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 subjects, aged ≥18 to <55 years (> 65 years for elderly cohort) at the time of informed consent
- •Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be >50 kg
- •Subjects who are healthy and free from clinically significant illness or disease
- •Females must be of non-childbearing potential, surgically sterile.
- •Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception
排除标准
- •Systolic blood pressure (SBP) <90 mmHg or >140 mmHg, diastolic blood pressure (DBP) <45 mmHg or >90 mmHg, resting pulse rate <40 beats per minute (bpm) or >100 bpm
- •Subjects who have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhoea or positive 13C urea breath/faecal test for Helicobacter pylori at Screening.
- •Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.
- •Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study, expose the subject to undue risk.
研究组 & 干预措施
GRC 27864
Active Comparator
Test treatment GRC 27864
干预措施: GRC 27864 (Drug)
Placebo
Placebo Comparator
Placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects
时间窗: Baseline upto 42 days after administration of the study drug.
次要结局
- Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Half-life (t½) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Time to Maximum Concentration (Tmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Clearance (CL)/F of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Observed accumulation ratio (Rac) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Area Under Curve [AUC0-t and AUC0-tau] of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Volume of distribution (V)/bioavailability (F) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.(Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28)
- Cerebrospinal fluid (CSF) concentrations of GRC 27864 and its metabolite GRC 27884 (CmaxCSF) following multiple doses to healthy adult subjects(6 hours, and 24 hours postdose on Day 26)
研究者
研究点 (1)
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