CompletedPhase EARLY_1

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

An Open Label Study to Evaluate the Safety and Gastric-Retentive Properties of Modified Release Capsules Containing Memantine Hydrochloride in Healthy Adults

Lead sponsor

Lyndra Inc.

Asset

LYN-057

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-40•MRI contraindications excluded

Primary endpoints

•Gastric retention by imaging assessment by MRI•Gastric retention by imaging assessment by abdominal U/S•Safety and tolerability of a single dose of LYN-057 extended release capsule

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

RegistryACTRN12618001426279ANZCTR

Secondary IDCM8718CMAX

Org study IDLYN-057-C-002

NCT IDNCT03711825

Timeline

Milestones

Study start2018-09-10actual

Primary completion2018-10-01actual

Study first posted2018-10-19actual

Study completion2018-11-13actual

Last update posted2019-02-26actual

Assets

Drug assets

LYN-057

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

1. Healthy male and female subjects

2. Body mass index of 18.0 to 30.0 kg/meters-squared

3. Suitable scores for two swallowing questionnaires

4. Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies

5. Must provide written informed consent

Exclusion criteria

1. Participants who have previously been enrolled in this study

2. History of any drug or alcohol abuse in the past 2 years

3. Current smokers and those who have smoked within the past 12 months

4. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof

5. Individuals with a positive test for HIV, hepatitis B or hepatitis C

6. Individuals who are contraindicated based on memantine HCl

7. Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule

8. Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing

9. Individuals with contraindication to MRI imaging

10. Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire

11. Individuals with contraindications to elective X-ray based on known or expected radiation exposure

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Neuroimaging

Other clinical outcomes

Other (unclassified)

Neuroimaging

1 endpoint

Primary/protocol endpoint

Gastric retention by imaging assessment by MRI

Time frame:Up to 9 days post-dosing

descriptive

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

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

Time frame:Through study completion, up to 3 months

event count, event

Secondary/protocol endpoint

Memantine HCl pharmacokinetics - Maximum Plasma Concentration (Cmax)

Time frame: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.

concentration, descriptive

Secondary/protocol endpoint

Memantine HCl pharmacokinetics - Time after administration of maximum plasma concentration (Tmax)

Time frame: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.

concentration, descriptive

Secondary/protocol endpoint

Memantine HCl pharmacokinetics - Area Under the Curve (AUC)

Time frame: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.

concentration, descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Gastric retention by imaging assessment by abdominal U/S

Time frame:Up to 9 days post-dosing

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Physical features of recovered formulation components

Time frame:Through study completion, up to 29 days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.