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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03711825




Registration number
NCT03711825
Ethics application status
Date submitted
14/10/2018
Date registered
19/10/2018

Titles & IDs
Public title
Study to Evaluate Safety/Duration in Stomach of Extended Release 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] 0 0
ACTRN12618001426279
Secondary ID [2] 0 0
LYN-057-C-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Gastric Retention 0 0
Healthy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LYN-057
Treatment: Surgery - Imaging Assessment (MRI)
Treatment: Surgery - Imaging Assessment (U/S)

Experimental: Sentinel/Main - Sentinel 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)


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

Treatment: Surgery: Imaging Assessment (MRI)
Imaging assessments \[MRI\] will be performed on specified days according to protocol

Treatment: Surgery: Imaging Assessment (U/S)
Imaging assessments (abdominal U/S) will be performed on specified days according to protocol
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gastric retention by imaging assessment by MRI
Timepoint [1] 0 0
Up to 9 days post-dosing
Primary outcome [2] 0 0
Gastric retention by imaging assessment by abdominal U/S
Timepoint [2] 0 0
Up to 9 days post-dosing
Primary outcome [3] 0 0
Safety and tolerability of a single dose of LYN-057 extended release capsule
Timepoint [3] 0 0
Through study completion, up to 3 months
Secondary outcome [1] 0 0
Memantine HCl pharmacokinetics - Maximum Plasma Concentration (Cmax)
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Memantine HCl pharmacokinetics - Time after administration of maximum plasma concentration (Tmax)
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Memantine HCl pharmacokinetics - Area Under the Curve (AUC)
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Physical features of recovered formulation components
Timepoint [4] 0 0
Through study completion, up to 29 days

Eligibility
Key inclusion criteria
1. Healthy male and female subjects
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 capsule, 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 relating 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 the date of dosing
9. Individuals with contraindication to MRI imaging
10. Individuals with functional constipation, irritable bowel, or functional diarrhea, 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
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2018
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lyndra Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, MD
Address 0 0
CMAX
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03711825