An Open Label Study to Evaluate the Safety and Gastric-Retentive Properties of Modified Release Capsules Containing Memantine Hydrochloride in Healthy Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and tolerability of a single dose of LYN-057 extended release capsule
研究概览
简要总结
To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound).
To evaluate the safety of a memantine HCl extended release capsule formulation
详细描述
This is a single centre, open label, single dose study in healthy adult subjects.
Eligible individuals will be admitted to an inpatient unit in two or more cohorts. Enough eligible individuals will be admitted allowing for the enrollment of the Sentinel (n= 2) and Main Group (total of n=8 in Main), and an optional Supplemental Group (n= 6), if required.
All enrolled subjects will be dosed with a single administration of an extended release capsule containing memantine hydrochloride (LYN-057), 50 mg. Dosing will be conducted in an inpatient clinical unit, with access to an acute care facility. Subjects will remain in the inpatient unit for 7 days after dosing. During this time, subjects will undergo intermittent imaging assessments for gastric retention [magnetic resonance imaging (MRI) and abdominal ultrasound (U/S)], safety assessments, blood sampling for evaluation of memantine pharmacokinetics (PK), and faecal collections for assessments of formulation components and bowel movement characteristics.
Subjects will return to the clinic for PK sampling and safety assessments on Days 10, 15, 22 and Day 29 (End of Study Visit). In addition, some subjects may continue to perform faecal collection and/or may undergo imaging assessments on Day 10 based on clinical criteria. On Day 29 (End of Study Visit), subjects will undergo final safety and PK assessments and will be discharged from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects
- •Body mass index of 18.0 to 30.0 kg/meters-squared
- •Suitable scores for two swallowing questionnaires
- •Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
- •Must provide written informed consent
排除标准
- •Participants who have previously been enrolled in this study
- •History of any drug or alcohol abuse in the past 2 years
- •Current smokers and those who have smoked within the past 12 months
- •Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
- •Individuals with a positive test for HIV, hepatitis B or hepatitis C
- •Individuals who are contraindicated based on memantine HCl
- •Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule
- •Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
- •Individuals with contraindication to MRI imaging
- •Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire
- •Individuals with contraindications to elective X-ray based on known or expected radiation exposure
研究组 & 干预措施
Sentinel/Main
Sentinel dosing of two subjects in clinic of LYN-057 (50 mg), followed by Main, i.e. remaining 6 subjects, for total of 8 subjects doses; followed by imaging assessment (MRI/abdominal U/S)
干预措施: LYN-057 (Drug)
Sentinel/Main
Sentinel dosing of two subjects in clinic of LYN-057 (50 mg), followed by Main, i.e. remaining 6 subjects, for total of 8 subjects doses; followed by imaging assessment (MRI/abdominal U/S)
干预措施: Imaging Assessment (MRI) (Procedure)
Sentinel/Main
Sentinel dosing of two subjects in clinic of LYN-057 (50 mg), followed by Main, i.e. remaining 6 subjects, for total of 8 subjects doses; followed by imaging assessment (MRI/abdominal U/S)
干预措施: Imaging Assessment (U/S) (Procedure)
结局指标
主要结局
Safety and tolerability of a single dose of LYN-057 extended release capsule
时间窗: Through study completion, up to 3 months
Safety collected from a combination of the following: Adverse Event (AE) reporting and examinations specified per protocol
Gastric retention by imaging assessment by MRI
时间窗: Up to 9 days post-dosing
Visualization of formulation/formulation components in stomach by MRI
Gastric retention by imaging assessment by abdominal U/S
时间窗: Up to 9 days post-dosing
Visualization of formulation/formulation components in stomach by abdominal U/S
次要结局
- Memantine HCl pharmacokinetics - Area Under the Curve (AUC)(Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.)
- Memantine HCl pharmacokinetics - Maximum Plasma Concentration (Cmax)(Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.)
- Physical features of recovered formulation components(Through study completion, up to 29 days)
- Memantine HCl pharmacokinetics - Time after administration of maximum plasma concentration (Tmax)(Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.)