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Trial registered on ANZCTR


Registration number
ACTRN12618001426279
Ethics application status
Approved
Date submitted
22/08/2018
Date registered
27/08/2018
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Study to Evaluate Safety and Duration in Stomach of Modified Release Prototype Capsules Containing Memantine Hydrochloride in Healthy Adults
Scientific title
An Open Label Study to Evaluate the Safety and Gastric-Retentive Properties of Modified Release Capsules Containing Memantine Hydrochloride in Healthy Adults
Secondary ID [1] 295874 0
LYN-057-C-002
Secondary ID [2] 295875 0
CM8718
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 309340 0
Condition category
Condition code
Neurological 308203 308203 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is LYN-057, a modified release (MR) prototype capsule containing memantine hydrochloride (HCl) (50 mg). The rationale for the development of this MR formulation is to reduce the frequency of dosing orally administered memantine HCl medications to once weekly or less and thereby improving the management of Alzheimer's disease.

The dose of LYN-057 to be given is a single Size 00EL capsule containing 50 mg memantine HCl within the MR formulation (stellate). One capsule (50 mg dose) will be administered to the participant. This single capsule dose will be administered by a trained nurse (at a minimum) in a clinic (for Sentinel, Main or, if required, Supplemental Dosing Groups).
Intervention code [1] 312207 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307173 0
Gastric retention assessed by imaging [Magnetic Resonance Imaging (MRI) or abdominal ultrasound (U/S)]
Timepoint [1] 307173 0
Days 1, 2, 4, 7 and 9 after dosing
Primary outcome [2] 307174 0
Safety and tolerability of memantine HCl (50 mg) MR prototype capsule. Adverse events will be collected from a composite/combination of the following:
1) Spontaneous adverse event reporting
2) Vital signs, physical examinations and pre-dose (Day 1) and post-dosing (Day 4 and 7) safety laboratory assessments (haematology, coagulation, liver function tests, clinical chemistry panel)
3) Examination of post-dosing bowel movements for blood
4) Use of systematic algorithm to evaluate moderate or severe abdominal pain, should it occur (including laboratory assessments, physical examination, imaging studies)
Timepoint [2] 307174 0
Adverse events, concomitant medications, vital signs, directed physical examinations will be conducted daily for 8 days during an inpatient admission for observation after dosing. After Day 8, participants will be discharged from the unit and will return for these assessments on Day 10, 15, 22, and 29. Safety laboratory assessments will be performed prior to dosing, at Day 4 and Day 7.
Secondary outcome [1] 350975 0
Memantine HCl pharmacokinetics [Cmax, Tmax, AUC (0-t)] by validated assay,
Timepoint [1] 350975 0
Pre-dose, on day of dosing at 2, 4, 6, 8, and 12 hours post dosing, thereafter daily during inpatient admission through Day. After Day 8, participants will be discharged from the unit and will return for PK/blood sampling on Day 10, 15, 22 and 29.
Secondary outcome [2] 350976 0
As an exploratory outcome, to summarise the physical features of the formulation/stellate recovered from collected faecal specimens, e.g., full vs. partial stellate vs. core only vs. arms only
Timepoint [2] 350976 0
Post-dosing
2, 4, 8, 12, 24, 48, 72, 96, 144 hours
Day 8, 10, 15, 22

Eligibility
Key inclusion criteria
1) Healthy male and female participants
2) Body mass index of 18.0 to 30.0 kg/meters-squared
3) Suitable scores for two swallowing questionnaires
4) Demonstrate normal swallowing and gastrointestinal passage for capsules, as assessed while undergoing imaging studies
5) Must provide written informed consent
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Participants who have previously been enrolled in this study
2) History of any drug or alcohol abuse in the past 2 years
3) Current smokers and those who have smoked within the past 12 months
4) Individuals with clinically significant medical history related to the gastrointestinal tract and potential complications, thereof
5) Individuals with a positive test for HIV, hepatitis B or hepatitis C
6) Individuals who are contraindicated based on memantine HCl
7) Serious adverse reaction or serious hypersensitivity to components of the study formulation or patency capsule
8) Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to date of dosing
9) Individuals with contraindication to MRI imaging
10) Individuals with functional constipation, irritable bowel or functional diarraheoa, as evaluated by standardized questionnaire
11) Individuals with contraindications to elective X-ray based on known or expected radiation exposure

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
10/09/2018
Date of last participant enrolment
Anticipated
Actual
24/09/2018
Date of last data collection
Anticipated
Actual
13/11/2018
Sample size
Target
14
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11706 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 23787 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300471 0
Commercial sector/Industry
Name [1] 300471 0
lyndra Australia Pty Ltd
Country [1] 300471 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lyndra Australia Pty Ltd.
Address
Level 13 41 Exhibition Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 299940 0
None
Name [1] 299940 0
Address [1] 299940 0
Country [1] 299940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301273 0
Bellberry Limited HREC Committee H
Ethics committee address [1] 301273 0
Ethics committee country [1] 301273 0
Australia
Date submitted for ethics approval [1] 301273 0
02/05/2018
Approval date [1] 301273 0
21/08/2018
Ethics approval number [1] 301273 0
2018-04-256

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3019 3019 0 0
/AnzctrAttachments/375847-ApprovalLetter-HREC2018-04-256.pdf (Ethics approval)

Contacts
Principal investigator
Name 86446 0
Prof Sepehr Shakib
Address 86446 0
CMAX
Level 5
18a North Terrace
Adelaide SA 5000
Country 86446 0
Australia
Phone 86446 0
+61 0870742823
Fax 86446 0
Email 86446 0
sepehr.shakib@sa.gov.au
Contact person for public queries
Name 86447 0
Jessica Ballinger
Address 86447 0
(Director)
Lyndra Australia Pty Ltd.
Level 13
41 Exhibition Street
Melbourne VIC 3000
Country 86447 0
Australia
Phone 86447 0
+1857-201-5322
Fax 86447 0
Email 86447 0
jballinger@lyndra.com
Contact person for scientific queries
Name 86448 0
Andrew M Bellinger
Address 86448 0
Lyndra Inc
65 Grove St
Suite 301
Watertown MA 02472
Country 86448 0
United States of America
Phone 86448 0
+1917-204-1167
Fax 86448 0
Email 86448 0
abellinger@lyndra.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This Phase 1 study was considered exploratory to inform later study designs.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.