Gastric Retention, Healthy
Conditions
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.
Interventions
DRUGMemantine Hydrochloride MR Prototype Capsule Formulation D
Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUGMemantine Hydrochloride MR Prototype Capsule Formulation E
Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUGMemantine Hydrochloride MR Prototype Capsule Formulation A
Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUGMemantine Hydrochloride MR Prototype Capsule Formulation B
Memantine HCl MR capsule formulation will be administered orally in a single dose
DRUGMemantine Hydrochloride MR Prototype Capsule Formulation C
Memantine HCl MR capsule formulation will be administered orally in a single dose
PROCEDUREMagnetic Resonance Imaging
MRI will be performed on specified days according to protocol
Sponsors
Lyndra Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Retention by Magnetic Resonance Imaging (MRI) | 7 Days | Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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
Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol | 3 |
| 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
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
Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol | 0 |
| 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
Memantine Hydrochloride MR Prototype Capsule Formulation E: Memantine HCl MR capsule formulation will be administered orally in a single dose
Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol stopping rules met | 3 |
Baseline characteristics
| Characteristic | Cohort 1 | Total |
|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 12.3 | 33.7 years STANDARD_DEVIATION 12.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Region of Enrollment United Kingdom | 3 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Gastric Retention by Magnetic Resonance Imaging (MRI)
Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing
Time frame: 7 Days
Population: Subjects who completed dosing and at least one MRI assessment after dosing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Gastric Retention by Magnetic Resonance Imaging (MRI) | 2 Participants |