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Alzheimer DiseaseEarly Phase 1NCT03711825

Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults

A Early Phase 1 study testing LYN-057, Imaging Assessment (MRI) and Imaging Assessment (U/S) in people with Alzheimer Disease and Gastric Retention, run by Lyndra Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound). To evaluate the safety of a memantine HCl extended release capsule formulation Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Gastric Retention, Healthy
What is being tested?
LYN-057, Imaging Assessment (MRI) and Imaging Assessment (U/S)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteAustralia
Study dates
10 Sep 2018to 13 Nov 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female subjects
  • Body mass index of 18.0 to 30.0 kg/meters-squared
  • Suitable scores for two swallowing questionnaires
  • Demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies
  • Must provide written informed consent

Who cannot join

  • Participants 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 past 12 months
  • Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
  • Individuals with a positive test for HIV, hepatitis B or hepatitis C
  • Individuals who are contraindicated based on memantine HCl
Show all 11Show fewer
  • Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule
  • Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
  • Individuals with contraindication to MRI imaging
  • Individuals with functional constipation, irritable bowel, or functional diarrhea, as evaluated by standardized questionnaire
  • Individuals with contraindications to elective X-ray based on known or expected radiation exposure

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: An Open Label Study to Evaluate the Safety and Gastric-Retentive Properties of Modified Release Capsules Containing Memantine Hydrochloride in Healthy Adults

To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound).

To evaluate the safety of a memantine HCl extended release capsule formulation

Read the detailed description

This is a single centre, open label, single dose study in healthy adult subjects.

Eligible individuals will be admitted to an inpatient unit in two or more cohorts. Enough eligible individuals will be admitted allowing for the enrollment of the Sentinel (n= 2) and Main Group (total of n=8 in Main), and an optional Supplemental Group (n= 6), if required.

All enrolled subjects will be dosed with a single administration of an extended release capsule containing memantine hydrochloride (LYN-057), 50 mg. Dosing will be conducted in an inpatient clinical unit, with access to an acute care facility. Subjects will remain in the inpatient unit for 7 days after dosing. During this time, subjects will undergo intermittent imaging assessments for gastric retention [magnetic resonance imaging (MRI) and abdominal ultrasound (U/S)], safety assessments, blood sampling for evaluation of memantine pharmacokinetics (PK), and faecal collections for assessments of formulation components and bowel movement characteristics.

Subjects will return to the clinic for PK sampling and safety assessments on Days 10, 15, 22 and Day 29 (End of Study Visit). In addition, some subjects may continue to perform faecal collection and/or may undergo imaging assessments on Day 10 based on clinical criteria. On Day 29 (End of Study Visit), subjects will undergo final safety and PK assessments and will be discharged from the study.

Being tested
LYN-057, Imaging Assessment (MRI), Imaging Assessment (U/S)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LYN-057Drug

    Also called LYN-057 (50 mg)

    Administration of single dose of LYN-057 presented as extended release capsule containing 50 mg of memantine hydrochloride (HCl)

  • Imaging Assessment (MRI)Procedure or surgery

    Also called MRI

    Imaging assessments [MRI] will be performed on specified days according to protocol

  • Imaging Assessment (U/S)Procedure or surgery

    Also called Abdominal Ultrasound

    Imaging assessments (abdominal U/S) will be performed on specified days according to protocol

Study groups in NCT03711825
Study groupRoleWhat they receive
Sentinel/MainExperimentalSentinel dosing of two subjects in clinic of LYN-057 (50 mg), followed by Main, i.e. remaining 6 subjects, for total of 8 subjects doses; followed by imaging assessment (MRI/abdominal U/S)
Receives: Drug: LYN-057; Procedure: Imaging Assessment (MRI); Procedure: Imaging Assessment (U/S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric retention by imaging assessment by MRI

    Visualization of formulation/formulation components in stomach by MRI

    Measured: Up to 9 days post-dosing

  2. Gastric retention by imaging assessment by abdominal U/S

    Visualization of formulation/formulation components in stomach by abdominal U/S

    Measured: Up to 9 days post-dosing

  3. Safety and tolerability of a single dose of LYN-057 extended release capsule

    Safety collected from a combination of the following: Adverse Event (AE) reporting and examinations specified per protocol

    Measured: Through study completion, up to 3 months

Secondary outcomes (4)

  1. Memantine HCl pharmacokinetics - Maximum Plasma Concentration (Cmax)

    Memantine HCl pharmacokinetics - Cmax by validated assay

    Measured: Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.

  2. Memantine HCl pharmacokinetics - Time after administration of maximum plasma concentration (Tmax)

    Memantine HCl pharmacokinetics - Tmax by validated assay

    Measured: Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.

  3. Memantine HCl pharmacokinetics - Area Under the Curve (AUC)

    Memantine HCl pharmacokinetics - AUC by validated assay

    Measured: Pre-dose, on day of dosing at 2, 4, 6, 8 and 12 hours post-dosing, thereafter daily during inpatient stay through Day 8. After Day 8, PK sampling on Day 10, 15, 22 and 29.

  4. Physical features of recovered formulation components

    Recording of the descriptive physical features, e.g. number of polymeric arms (if separate) or attached to the core, of formulation components recovered from collected fecal specimens

    Measured: Through study completion, up to 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2018
  2. Study start10 Sep 2018
  3. Primary completion1 Oct 2018
  4. Study completion13 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711825
Sponsor's protocol ID
LYN-057-C-002
Other IDs
ACTRN12618001426279, CM8718
Status last verified
Feb 2019
First submitted
14 Oct 2018
Last updated
26 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LYN-057, Imaging Assessment (MRI) and Imaging Assessment (U/S) in people with Alzheimer Disease and Gastric Retention, run by Lyndra Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric retention by imaging assessment by MRI (time frame: Up to 9 days post-dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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