CompletedEarly Phase 1

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

Australia8 participantsStarted 2018-09-10

Plain-language 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

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Gastric retention by imaging assessment by MRI

Timeframe: Up to 9 days post-dosing

Gastric retention by imaging assessment by abdominal U/S

Timeframe: Up to 9 days post-dosing

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

Timeframe: Through study completion, up to 3 months

Trial details

NCT IDNCT03711825

SponsorLyndra Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-01

View on ClinicalTrials.gov More Alzheimer Disease trials

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Gastric retention by imaging assessment by MRI

Timeframe: Up to 9 days post-dosing

Gastric retention by imaging assessment by abdominal U/S

Timeframe: Up to 9 days post-dosing

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

Timeframe: Through study completion, up to 3 months