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

Lyndra

Status and phase: Terminated; Early Phase 1

Conditions: Healthy; Gastric Retention

Treatments: Procedure: Magnetic Resonance Imaging; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation C; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation D; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation A; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation B; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation E

Study type: Interventional

Funder types: Industry

Identifiers

NCT03468543

2017-000982-61 (EudraCT Number)

QCL117924

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects.
2. Body mass index of 18.0 to 32.0 kg/m2.
3. Subjects must demonstrate their ability to swallow a test capsule at screening.
4. Must provide written informed consent.

Exclusion criteria

1. Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
2. Subjects who have previously been enrolled in this study.
3. History of any drug or alcohol abuse in the past 2 years.
4. Current smokers and those who have smoked within the last 12 months.
5. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
7. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
8. Individuals with contraindication to MRI imaging.

Other protocol defined criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days

Treatment:

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation B

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation A

Procedure: Magnetic Resonance Imaging

Cohort 2

Experimental group

Description:

Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days

Treatment:

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation D

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation C

Procedure: Magnetic Resonance Imaging

Cohort 3

Experimental group

Description:

Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days

Treatment:

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation E

Procedure: Magnetic Resonance Imaging