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

NCT ID: NCT03468543

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2017-09-18

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

Memantine Hydrochloride MR Prototype Capsule Formulation A

Intervention Type: DRUG

Memantine HCl MR capsule formulation will be administered orally in a single dose

Memantine Hydrochloride MR Prototype Capsule Formulation B

Intervention Type: DRUG

Memantine HCl MR capsule formulation will be administered orally in a single dose

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

MRI will be performed on specified days according to protocol

Cohort 2

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

Group Type: EXPERIMENTAL

Memantine Hydrochloride MR Prototype Capsule Formulation C

Intervention Type: DRUG

Memantine HCl MR capsule formulation will be administered orally in a single dose

Memantine Hydrochloride MR Prototype Capsule Formulation D

Intervention Type: DRUG

Memantine HCl MR capsule formulation will be administered orally in a single dose

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

MRI will be performed on specified days according to protocol

Cohort 3

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

Group Type: EXPERIMENTAL

Memantine Hydrochloride MR Prototype Capsule Formulation E

Intervention Type: DRUG

Memantine HCl MR capsule formulation will be administered orally in a single dose

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

MRI will be performed on specified days according to protocol

Interventions

Memantine Hydrochloride MR Prototype Capsule Formulation A

Memantine HCl MR capsule formulation will be administered orally in a single dose

Intervention Type: DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation B

Memantine HCl MR capsule formulation will be administered orally in a single dose

Intervention Type: DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation C

Memantine HCl MR capsule formulation will be administered orally in a single dose

Intervention Type: DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation D

Memantine HCl MR capsule formulation will be administered orally in a single dose

Intervention Type: DRUG

Memantine Hydrochloride MR Prototype Capsule Formulation E

Memantine HCl MR capsule formulation will be administered orally in a single dose

Intervention Type: DRUG

Magnetic Resonance Imaging

MRI will be performed on specified days according to protocol

Intervention Type: PROCEDURE

Other Intervention Names

Memantine HCl Capsule Formulation A (50 mg); Memantine HCl Capsule Formulation B (50 mg); Memantine HCl Capsule Formulation C (50 mg); Memantine HCl Capsule Formulation D (50 mg); Memantine HCl Capsule Formulation E (50 mg); MRI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lyndra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Mair, MBChB, DRCOG

Role: STUDY_DIRECTOR

Quotient Clinical

Locations

Quotient Sciences (formerly Quotient Clinical)

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-000982-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

QCL117924

Identifier Type: -

Identifier Source: org_study_id