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NCT03468543 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03468543
Other study ID # QCL117924
Secondary ID 2017-000982-61
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date July 26, 2017
Est. completion date September 18, 2017

Study information
Verified date August 2018
Source Lyndra Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date September 18, 2017
Est. primary completion date September 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Memantine Hydrochloride MR Prototype Capsule Formulation A
Memantine HCl MR capsule formulation will be administered orally in a single dose
• Memantine Hydrochloride MR Prototype Capsule Formulation B
Memantine HCl MR capsule formulation will be administered orally in a single dose
• Memantine Hydrochloride MR Prototype Capsule Formulation C
Memantine HCl MR capsule formulation will be administered orally in a single dose
• Memantine Hydrochloride MR Prototype Capsule Formulation D
Memantine HCl MR capsule formulation will be administered orally in a single dose
• 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

Locations
Country Name City State
United Kingdom Quotient Sciences (formerly Quotient Clinical) Ruddington Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Lyndra Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric Retention by Magnetic Resonance Imaging (MRI) Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing 7 Days
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