None listed
Conditions
Brief summary
To assess how long memantine HCl (50 mg) modified release prototype capsules stay in the stomach, as determined by imaging assessments (MRI or abdominal ultrasound) To evaluate the safety of memantine HCl modified release capsule formulations
Interventions
The intervention is LYN-057, a modified release (MR) prototype capsule containing memantine hydrochloride (HCl) (50 mg). The rationale for the development of this MR formulation is to reduce the frequency of dosing orally administered memantine HCl medications to once weekly or less and thereby improving the management of Alzheimer's disease.
The dose of LYN-057 to be given is a single Size 00EL capsule containing 50 mg memantine HCl within the MR formulation (stellate). One capsule (50 mg do
The intervention is LYN-057, a modified release (MR) prototype capsule containing memantine hydrochloride (HCl) (50 mg). The rationale for the development of this MR formulation is to reduce the frequency of dosing orally administered memantine HCl medications to once weekly or less and thereby improving the management of Alzheimer's disease. The dose of LYN-057 to be given is a single Size 00EL capsule containing 50 mg memantine HCl within the MR formulation (stellate). One capsule (50 mg dose) will be administered to the participant. This single capsule dose will be administered by a trained nurse (at a minimum) in a clinic (for Sentinel, Main or, if required, Supplemental Dosing Groups).
Sponsors
Lyndra Australia Pty Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1) Healthy male and female participants 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 capsules, 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 related 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 date of dosing 9) Individuals with contraindication to MRI imaging 10) Individuals with functional constipation, irritable bowel or functional diarraheoa, as evaluated by standardized questionnaire 11) Individuals with contraindications to elective X-ray based on known or expected radiation exposure
Outcome results
None listed