A Phase I, Single-Center, Single Dose Study to Evaluate the Effect of Food, Gender, and Age on Safety and Pharmacokinetic Profiles of SUVN-911 Tablets Orally Administered in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under concentration (AUC)
研究概览
简要总结
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
详细描述
This is a Phase I, single-center, open-label, single dose study to evaluate the effect of food, gender, and age on the safety and Pharmacokinetic profiles of single doses of SUVN-911, administered orally in healthy subjects.
The primary objective is to evaluate the effect of food, gender, and age on the pharmacokinetics of a single dose of SUVN-911 administered orally to healthy subjects.
The secondary objective is to evaluate the safety and tolerability of a single dose of SUVN-911 administered orally to healthy adult male, female, and elderly subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 18 to 45 years of age (inclusive) for Cohort 1, healthy female subjects, 18 to 45 years of age (inclusive) for Cohort 2, and healthy male subjects ≥ 65 years of age (inclusive) for Cohort 3, at the time of signing the informed consent.
- •Subjects in Cohorts 1 and 2 must have a body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive). Elderly subjects in Cohort 3 must have a body weight of at least 50 kg and BMI within the range of 18 to 32 kg/m2 (inclusive)
排除标准
- •History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure, or trauma within 28 days of the first administration of the study treatment (Day 1).
- •Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
- •Any positive result at Screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
研究组 & 干预措施
Food Effect Cohort
Twelve healthy male subjects 18 to 45 years of age, inclusive, will be administered a single oral dose of SUVN-911 on Day 1 (Period 1) and Day 8 (Period 2) with and without food in a crossover manner.
干预措施: SUVN-911 (Drug)
Gender Effect Cohort
Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911.
干预措施: SUVN-911 (Drug)
Age Effect Cohort
Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911.
干预措施: SUVN-911 (Drug)
结局指标
主要结局
Area under concentration (AUC)
时间窗: 24 hours
Plasma concentration versus time
次要结局
- Vital signs(24 hours)