An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- PK parameters of imeglimin
研究概览
简要总结
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •BMI : 18.5-29.9
- •Body weight ≥ 60 kg
- •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
- •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
Open-label imeglimin + cimetidine
Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine
干预措施: Imeglimin (Drug)
Open-label imeglimin + cimetidine
Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine
干预措施: Cimetidine (Drug)
结局指标
主要结局
PK parameters of imeglimin
时间窗: At Day 1
Cmax: peak plasma concentration after dosing
次要结局
- PK parameters of imeglimin(From day 1 to day 3)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](from day 1 to day 17)