A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Safety and tolerability of co-administered baclofen and memantine via C-SSRS
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and obese (Part B), otherwise healthy subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females aged 18 to 45 years inclusive;
- •Subjects with body mass index:
- •For Part A: ≥18 kg/m² and ≤25 kg/m²; For Part B: ≥33 kg/m² and ≤40 kg/m².
- •Subjects with a total body weight of ≥50 kg (Part A and Part B);
- •Subjects who are healthy as determined by the Investigator based on pre study medical history, physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and 12-lead ECG at screening and each admission;
- •Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;
- •Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);
- •Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
- •Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;
- •Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;
- •Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or
- •≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;
- •Subjects who are able and willing to give written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Healthy Volunteers
干预措施: Baclofen (Drug)
Healthy Volunteers
干预措施: Memantine (Drug)
Obese, Otherwise Healthy Volunteers
干预措施: Baclofen (Drug)
Obese, Otherwise Healthy Volunteers
干预措施: Memantine (Drug)
Obese, Otherwise Healthy Volunteers
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of co-administered baclofen and memantine via C-SSRS
时间窗: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via ECG
时间窗: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Vital Signs
时间窗: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Clinical Laboratory Tests
时间窗: From Baseline until Follow-up
Safety and tolerability of co-administered baclofen and memantine via Adverse Events
时间窗: From Baseline until Follow-up
次要结局
- Pharmacokinetic parameters of co-administered baclofen and memantine via Tmax(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via T1/2(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via AUC(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via MRT(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via Cmax(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via CL/F(From Baseline until Day 32)
- Pharmacokinetic parameters of co-administered baclofen and memantine via CLR(From Baseline until Day 32)