NCT03468543

Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

Detailed description

This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2. Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration. Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.

Conditions

• Gastric Retention
• Healthy

Interventions

Type	Name	Description
DRUG	Memantine Hydrochloride MR Prototype Capsule Formulation A	Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUG	Memantine Hydrochloride MR Prototype Capsule Formulation B	Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUG	Memantine Hydrochloride MR Prototype Capsule Formulation C	Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUG	Memantine Hydrochloride MR Prototype Capsule Formulation D	Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUG	Memantine Hydrochloride MR Prototype Capsule Formulation E	Memantine HCl MR capsule formulation will be administered orally in a single dose
PROCEDURE	Magnetic Resonance Imaging	MRI will be performed on specified days according to protocol

Timeline

• Start date: 2017-07-26
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2018-03-16
• Last updated: 2019-06-05
• Results posted: 2019-06-05

Locations

1 site across 1 country: United Kingdom