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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000982-61 | EudraCT Number |
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Per protocol stopping rules
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To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine Hydrochloride MR Prototype Capsule Formulation A | Drug | Memantine HCl MR capsule formulation will be administered orally in a single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair, MBChB, DRCOG | Quotient Clinical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences (formerly Quotient Clinical) | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 did NOT get administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 |
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| Memantine Hydrochloride MR Prototype Capsule Formulation B | Drug | Memantine HCl MR capsule formulation will be administered orally in a single dose |
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| Memantine Hydrochloride MR Prototype Capsule Formulation C | Drug | Memantine HCl MR capsule formulation will be administered orally in a single dose |
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| Memantine Hydrochloride MR Prototype Capsule Formulation D | Drug | Memantine HCl MR capsule formulation will be administered orally in a single dose |
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| Memantine Hydrochloride MR Prototype Capsule Formulation E | Drug | Memantine HCl MR capsule formulation will be administered orally in a single dose |
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| Magnetic Resonance Imaging | Procedure | MRI will be performed on specified days according to protocol |
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| COMPLETED |
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| NOT COMPLETED |
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Cohorts 2 and 3 were not executed, as the study was stopped during Cohort 1
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastric Retention by Magnetic Resonance Imaging (MRI) | Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing | Subjects who completed dosing and at least one MRI assessment after dosing | Posted | Count of Participants | Participants | 7 Days |
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Adverse events were collected for five weeks after each dose of study drug.
Additional information:
Adverse events were collected for five weeks after each dose of study drug in Cohort 1 only. Cohorts 2 and 3 were not performed as the study was stopped, therefore the number of participants at risk for AE's (all types) is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 was NOT administered Magnetic Resonance Imaging: MRI will be performed on specified days according to protocol | 0 | 3 | 1 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| foreign body | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment | medication stuck in throat |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| presyncope | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
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| crying | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| non-cardiac chest pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| anxiety | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
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| abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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The trial was prematurely ended after the dosing of three subjects.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Bellinger, MD, PhD | Lyndra | 857-302-7878 | abellinger@lyndra.com |
| Feb 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008559 | Memantine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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