Healthy Clinical Trial
Official title:
An Open Label Study to Evaluate the Safety and Gastric-Retentive Properties of Modified Release Capsules Containing Memantine Hydrochloride in Healthy Adults
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
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.
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