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Trial registered on ANZCTR


Registration number
ACTRN12618000991213
Ethics application status
Approved
Date submitted
7/06/2018
Date registered
13/06/2018
Date last updated
15/02/2019
Date data sharing statement initially provided
15/02/2019
Date results information initially provided
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Duration in Stomach of Modified Release Prototype 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 in Healthy Adults
Secondary ID [1] 295045 0
LYN-PLT-C-001
Secondary ID [2] 295046 0
CM8818
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-adherence to medicines 308087 0
Condition category
Condition code
Metabolic and Endocrine 307131 307131 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is LYN-PLT, a modified release (MR) prototype capsule containing inactive ingredients. The rationale for development of this MR formulation is to reduce the frequency of dosing of orally-administered medications to once weekly or less and thereby improving the management of acute and chronic diseases.

The dose of LYN-PLT to be given is a single Size 00EL capsule containing less than 300 mg sucrose within the formulation's MR formulation (stellate). The capsule will be administered once by a trained nurse (at a minimum) in a hospital (Group 1 and Group 2) or clinic (Group 3, Group 4, and Group 5).

There are four arms: Formulation A, Formulation B, Formulation C, and Formulation D with each arm/capsule containing a different type of proprietary stellate.

Participants will be randomised to receive only one of the five study formulations (A-E).
Intervention code [1] 301380 0
Treatment: Drugs
Comparator / control treatment
Single oral dose of placebo capsule, containing microcrystalline cellulose, (Formulation E) will be delivered. Participants will be randomised to receive only one of the five study formulations (A, B, C, D or E).
Control group
Placebo

Outcomes
Primary outcome [1] 306115 0
Gastric retention assessed by Magnetic Resonance Imaging (MRI)
Timepoint [1] 306115 0
Days 1, 2, 4, 7 and 9 after dosing
Primary outcome [2] 306116 0
Safety and tolerability of several modified release (MR) capsules and a placebo capsule. Adverse events will be collected from a 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, liver function tests, clinical chemistry panel)
3) Examination of post-dosing bowel movements for blood
4) Use of a systematic algorithm to evaluate abdominal pain, should it occur (including laboratory assessments, physical examination, imaging studies)
Clinically significantly abnormal findings for items 2) through 4) will be reported as adverse events.
Timepoint [2] 306116 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] 347605 0
Gastric retention assessed by abdominal ultrasound (U/S)
Timepoint [1] 347605 0
Days 1, 2, 4, 7, 9 after dosing
Secondary outcome [2] 347606 0
Confirm oesophageal clearance of several MR capsules and a placebo capsule.
Timepoint [2] 347606 0
In Group 1 and Group 2, post dosing endoscopy will be performed approximately 2 hours after dosing to confirm oesophageal transit to the stomach.
Secondary outcome [3] 347607 0
To summarise the physical features of the formulation/stellate recovered from collected faecal specimens
Timepoint [3] 347607 0
0, 4, 8, 12, 24, 48, 72, 96, 120, 144 hours.
Day 8, 10, 15, 22

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 of capsules, as assessed while undergoing imaging studies
5) Must provide written informed consent
Minimum age
18 Years
Maximum age
40 Years
Gender
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 diarrheoa, 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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11081 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 22892 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299630 0
Commercial sector/Industry
Name [1] 299630 0
Lyndra Australia Pty Ltd.
Address [1] 299630 0
Level 13 41 Exhibition Street
Melbourne VIC 3000
Country [1] 299630 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] 299031 0
None
Name [1] 299031 0
Address [1] 299031 0
Country [1] 299031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300528 0
Bellberry Limited
Ethics committee address [1] 300528 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 300528 0
Australia
Date submitted for ethics approval [1] 300528 0
02/05/2018
Approval date [1] 300528 0
05/06/2018
Ethics approval number [1] 300528 0
2018-04-263

Summary
Brief summary
To assess how long modified release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
To evaluate the safety of several modified release capsule formulations and a placebo capsule.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83950 0
Prof Sepehr Shakib
Address 83950 0
CMAX
Level 5
18a North Terrace
Adelaide SA 5000
Country 83950 0
Australia
Phone 83950 0
+61 0870742823
Fax 83950 0
Email 83950 0
sepehr.shakib@sa.gov.au
Contact person for public queries
Name 83951 0
Ms Jessica Ballinger
Address 83951 0
(Director)
Lyndra Australia Pty Ltd.
Level 13
41 Exhibition St
Melbourne VIC 3000
Country 83951 0
Australia
Phone 83951 0
+1 857-201-5322
Fax 83951 0
Email 83951 0
jballinger@lyndra.com
Contact person for scientific queries
Name 83952 0
Dr Andrew M Bellinger
Address 83952 0
Lyndra Inc
65 Grove St
Suite 301
Watertown, MA 02472
Country 83952 0
United States of America
Phone 83952 0
+1 917 204 1167
Fax 83952 0
Email 83952 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
As this study is Phase 1 with the intent to inform future development of product with active ingredients, the Sponsor has concluded not to share IPD.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary