Healthy Clinical Trial
Official title:
A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Gastric Retention Properties of Modified Release Prototype Capsules (LYN-PLT) in Healthy Adults
To assess how long extended release prototype capsule formulations stay in the stomach as
determined by magnetic resonance imaging (MRI).
To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a
placebo capsule.
This is a multicentre, observer blind, randomised, single dose study in healthy adult
subjects.
The first 5 subjects enrolled into the study will be regarded as Dosing Group 1 (sentinel
group) and assigned to each of the five available study formulations. Dosing of subjects in
Dosing Groups 1 and 2 will be performed at the endoscopy centre. Dosing of subjects in Dosing
Groups 3 through 5 will be performed at the clinical site.
Subjects remain in the inpatient unit for 7 days after dosing. During this time, subjects
undergo intermittent imaging assessments for gastric retention (MRI and abdominal U/S),
safety assessments and faecal collections for assessments of retrieved components and bowel
movement characteristics.
Subjects return to the clinic on Days 10, 15, 22 and 29 (End of Study visit). Safety
assessments will be performed at all visits. MRI, abdominal U/S and outpatient faecal
collections may continue based on the clinical findings from subjects dosed with modified
release capsule formulations. On Day 29, the subjects will undergo final safety assessments
at the clinic and thereafter, will be discharged from the study.
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