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

NCT03468543 | Terminated Early Phase 1 Results

• 2 other identifiers: QCL1179242017-000982-61
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastric Retention; Healthy

Outcome Measures

Primary Outcomes (1)

• Gastric Retention by Magnetic Resonance Imaging (MRI)

  Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing

  7 Days

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation A; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation B; Procedure: Magnetic Resonance Imaging

Cohort 2

EXPERIMENTAL

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

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation C; Drug: Memantine Hydrochloride MR Prototype Capsule Formulation D; Procedure: Magnetic Resonance Imaging

Cohort 3

EXPERIMENTAL

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

Drug: Memantine Hydrochloride MR Prototype Capsule Formulation E; Procedure: Magnetic Resonance Imaging

Interventions

Memantine Hydrochloride MR Prototype Capsule Formulation A DRUG

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

Also known as: Memantine HCl Capsule Formulation A (50 mg)

Cohort 1

Memantine Hydrochloride MR Prototype Capsule Formulation B DRUG

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

Also known as: Memantine HCl Capsule Formulation B (50 mg)

Cohort 1

Memantine Hydrochloride MR Prototype Capsule Formulation C DRUG

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

Also known as: Memantine HCl Capsule Formulation C (50 mg)

Cohort 2

Memantine Hydrochloride MR Prototype Capsule Formulation D DRUG

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

Also known as: Memantine HCl Capsule Formulation D (50 mg)

Cohort 2

Memantine Hydrochloride MR Prototype Capsule Formulation E DRUG

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

Also known as: Memantine HCl Capsule Formulation E (50 mg)

Cohort 3

Magnetic Resonance Imaging PROCEDURE

MRI will be performed on specified days according to protocol

Also known as: MRI

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lyndra Inc.: lead

Study Sites (1)

Quotient Sciences (formerly Quotient Clinical)

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Memantine; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

The trial was prematurely ended after the dosing of three subjects.

Results Point of Contact

• Title: Andrew Bellinger, MD, PhD
• Organization: Lyndra

abellinger@lyndra.com

857-302-7878

Study Officials

• Stuart Mair, MBChB, DRCOG

  Quotient Clinical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 16, 2018
• Study Start: July 26, 2017
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)