Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults

NCT03711825 | Completed Early Phase 1

• 3 other identifiers: LYN-057-C-002ACTRN12618001426279CM8718
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease; Gastric Retention; Healthy

Outcome Measures

Primary Outcomes (3)

• Gastric retention by imaging assessment by MRI

  Visualization of formulation/formulation components in stomach by MRI

  Up to 9 days post-dosing

• Gastric retention by imaging assessment by abdominal U/S

  Visualization of formulation/formulation components in stomach by abdominal U/S

  Up to 9 days post-dosing

• Safety and tolerability of a single dose of LYN-057 extended release capsule

  Safety collected from a combination of the following: Adverse Event (AE) reporting and examinations specified per protocol

  Through study completion, up to 3 months

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• Physical features of recovered formulation components

  Through study completion, up to 29 days

Study Arms (1)

Sentinel/Main

EXPERIMENTAL

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)

Drug: LYN-057; Procedure: Imaging Assessment (MRI); Procedure: Imaging Assessment (U/S)

Interventions

LYN-057 DRUG

Administration of single dose of LYN-057 presented as extended release capsule containing 50 mg of memantine hydrochloride (HCl)

Also known as: LYN-057 (50 mg)

Sentinel/Main

Imaging Assessment (MRI) PROCEDURE

Imaging assessments \[MRI\] will be performed on specified days according to protocol

Also known as: MRI

Sentinel/Main

Imaging Assessment (U/S) PROCEDURE

Imaging assessments (abdominal U/S) will be performed on specified days according to protocol

Also known as: Abdominal Ultrasound

Sentinel/Main

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lyndra Inc.: lead

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sepehr Shakib, MD

  CMAX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 19, 2018
• Study Start: September 10, 2018
• Primary Completion: October 1, 2018
• Study Completion: November 13, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)