NCT03718390

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

A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Gastric Retention Properties of Modified Release Prototype Capsules (LYN-PLT) in Healthy Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Retention
• Healthy

Interventions

Type	Name	Description
DRUG	Formulation A	Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
DRUG	Formulation B	Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
DRUG	Formulation C	Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
DRUG	Formulation D	Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
DRUG	Formulation E	Placebo Capsule containing microcrystalline cellulose
PROCEDURE	Endoscopy	Endoscopy at 2 hours post dosing
PROCEDURE	Magnetic Resonance Imaging	MRI will be performed on specified days according to protocol

Timeline

• Start date: 2018-06-25
• Primary completion: 2018-09-15
• Completion: 2018-11-02
• First posted: 2018-10-24
• Last updated: 2019-02-26

Locations

1 site across 1 country: Australia