A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin
研究概览
简要总结
This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.
详细描述
Combined single and repeated dose groups with 3 escalating doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- •Body mass index in the range 18.0-25.0 kg/m2
- •Willing to use reliable contraception
- •Able to give fully informed written consent.
排除标准
- •Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
- •Clinically relevant abnormal findings at the screening assessment
- •Clinically significant vital signs outside the acceptable range at screening
- •Clinically relevant abnormal medical history, surgery or concurrent medical condition
- •Acute or chronic illness
- •Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
- •Severe adverse reaction to any drug or sensitivity to the trial medication or its components
- •Significant food allergy; vegetarian or vegan
- •Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
- •Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
- •Drug or alcohol abuse
- •Smoking of more than 5 cigarettes daily
- •Possibility that subject will not cooperate
- •Positive test for hepatitis B & C, HIV
- •Objection by a General Practitioner.
研究组 & 干预措施
Group A1
Dose 1 or placebo
干预措施: Imeglimin (Drug)
Group A1
Dose 1 or placebo
干预措施: Placebo (Drug)
Group A2
Dose 2 or placebo
干预措施: Imeglimin (Drug)
Group A2
Dose 2 or placebo
干预措施: Placebo (Drug)
Group A3
Dose 3 or placebo
干预措施: Imeglimin (Drug)
Group A3
Dose 3 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin
时间窗: From baseline to Day 13
* Cmax: peak plasma concentration after dosing * AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time * AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration * Tmax: time of peak plasma concentration of imeglimin
Safety and tolerability of imeglimin: laboratory assessments
时间窗: From baseline to Day 13
* routine hematology, biochemistry, coagulation and urinalysis * physical examination * 12-lead ECG * vital signs * capillary glucose * incidence of adverse events
次要结局
未报告次要终点