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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03718390




Registration number
NCT03718390
Ethics application status
Date submitted
14/10/2018
Date registered
24/10/2018
Date last updated
26/02/2019

Titles & IDs
Public title
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
Scientific title
A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Gastric Retention Properties of Modified Release Prototype Capsules (LYN-PLT) in Healthy Adults
Secondary ID [1] 0 0
ACTRN12618000991213
Secondary ID [2] 0 0
LYN-PLT-C-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Retention 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Formulation A
Treatment: Drugs - Formulation B
Treatment: Drugs - Formulation C
Treatment: Drugs - Formulation D
Treatment: Drugs - Formulation E
Treatment: Surgery - Endoscopy
Treatment: Surgery - Magnetic Resonance Imaging

Experimental: Sentinel Group 1 LYN-PLT - Sentinel dosing in endoscopy center of one of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized randomized, observer blind) and evaluation of gastric retention by MRI

Experimental: Sentinel Group 2 LYN-PLT - Sentinel dosing (second) in endoscopy center of one of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized randomized, observer blind) and evaluation of gastric retention by MRI

Experimental: Group 3 LYN-PLT - Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind). and evaluation of gastric retention by MRI

Experimental: Group 4 LYN-PLT - Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind) and evaluation of gastric retention by MRI

Experimental: Group 5 LYN-PLT - Dosing in clinic of two of each formulation (A, B, C, D, E) in a 1:1:1:1:1 ratio (centralized, randomized, observer blind) and evaluation of gastric retention by MRI.


Treatment: Drugs: Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation

Treatment: Drugs: Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation

Treatment: Drugs: Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation

Treatment: Drugs: Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation

Treatment: Drugs: Formulation E
Placebo Capsule containing microcrystalline cellulose

Treatment: Surgery: Endoscopy
Endoscopy at 2 hours post dosing

Treatment: Surgery: Magnetic Resonance Imaging
MRI 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 assessed by Magnetic Resonance Imaging (MRI)
Timepoint [1] 0 0
Up to 9 Days post-dosing
Primary outcome [2] 0 0
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports
Timepoint [2] 0 0
Through study completion, up to 6 months
Primary outcome [3] 0 0
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on changes in examinations pre (Day 1) and post dosing (Days 4 and 7)
Timepoint [3] 0 0
Through study completion, up to 6 months
Primary outcome [4] 0 0
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on post dosing evaluation of bowel movements for blood
Timepoint [4] 0 0
Through study completion, up to 6 months
Primary outcome [5] 0 0
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting
Timepoint [5] 0 0
Through study completion, up to 6 months
Secondary outcome [1] 0 0
Gastric retention assessed by abdominal ultrasound (U/S)
Timepoint [1] 0 0
Up to 9 Days post-dosing
Secondary outcome [2] 0 0
Confirm esophageal clearance of several MR capsules and a placebo capsule
Timepoint [2] 0 0
2 hours post dosing
Secondary outcome [3] 0 0
Physical Feature of Recovered Formulation Components
Timepoint [3] 0 0
Through study completion up to Day 29

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. Serious adverse reaction or serious hypersensitivity to components of the study
formulations or patency capsule

7. Individuals who have received any experimental agent within 30 days (or 5 half-lives),
whichever is longer, prior to the date of dosing

8. Individuals with contraindication to MRI imaging

9. Individuals with functional constipation, irritable bowel, or functional diarrhea, as
evaluated by standardized questionnaire

10. Individuals with contraindications to elective X-ray based on known or expected
radiation exposure

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
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
25/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2018
Sample size
Target
Accrual to date
Final
40
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
To assess how long extended release prototype capsule formulations stay in the stomach as
determined by magnetic resonance imaging (MRI).

To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a
placebo capsule.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03718390
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