Gastric RetentionEarly Phase 1NCT03718390
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
A Early Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Gastric Retention and Healthy, run by Lyndra Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Retention, Healthy
- What is being tested?
- Formulation A, Formulation B and Formulation C
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2018to 2 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
- Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule
Show all 10Show fewer
- 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.
About this study
Official 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
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.
Read the detailed description
This is a multicentre, observer blind, randomised, single dose study in healthy adult subjects.
The first 5 subjects enrolled into the study will be regarded as Dosing Group 1 (sentinel group) and assigned to each of the five available study formulations. Dosing of subjects in Dosing Groups 1 and 2 will be performed at the endoscopy centre. Dosing of subjects in Dosing Groups 3 through 5 will be performed at the clinical site.
Subjects remain in the inpatient unit for 7 days after dosing. During this time, subjects undergo intermittent imaging assessments for gastric retention (MRI and abdominal U/S), safety assessments and faecal collections for assessments of retrieved components and bowel movement characteristics.
Subjects return to the clinic on Days 10, 15, 22 and 29 (End of Study visit). Safety assessments will be performed at all visits. MRI, abdominal U/S and outpatient faecal collections may continue based on the clinical findings from subjects dosed with modified release capsule formulations. On Day 29, the subjects will undergo final safety assessments at the clinic and thereafter, will be discharged from the study.
- Conditions
- Gastric Retention, Healthy
- Being tested
- Formulation A, Formulation B, Formulation C, Formulation D, Formulation E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ADrug
Also called LYN-PLT Formulation A
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation BDrug
Also called LYN-PLT Formulation B
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation CDrug
Also called LYN-PLT Formulation C
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation DDrug
Also called LYN-PLT Formulation D
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Formulation EDrug
Also called Placebo capsule
Placebo Capsule containing microcrystalline cellulose
EndoscopyProcedure or surgery
Endoscopy at 2 hours post dosing
Magnetic Resonance ImagingProcedure or surgery
Also called MRI
MRI will be performed on specified days according to protocol
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Group 1 LYN-PLT | Experimental | 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 Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Procedure: Endoscopy; Procedure: Magnetic Resonance Imaging |
| Sentinel Group 2 LYN-PLT | Experimental | 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 Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Procedure: Endoscopy; Procedure: Magnetic Resonance Imaging |
| Group 3 LYN-PLT | Experimental | 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 Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Procedure: Magnetic Resonance Imaging |
| Group 4 LYN-PLT | Experimental | 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 Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Procedure: Magnetic Resonance Imaging |
| Group 5 LYN-PLT | Experimental | 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. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric retention assessed by Magnetic Resonance Imaging (MRI)
Visualization of formulation/formulation components in the stomach by MRI
Measured: Up to 9 Days post-dosing
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports
The number of confirmed gastrointestinal adverse events will be reported based on spontaneous adverse event reporting
Measured: Through study completion, up to 6 months
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)
Clinically significant aggregate changes in vital signs, physical examinations and safety laboratory assessments (haematology, liver function tests, clinical chemistry panel) between pre-dose (Day 1) and post-dosing (Day 4 and 7) will be reported as AE's
Measured: Through study completion, up to 6 months
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
Examination and reporting of post-dosing bowel movements for blood; clinically significant abnormal findings will be reported as AE's.
Measured: Through study completion, up to 6 months
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting
If abdominal pain occurs, a systematic algorithm to evaluate abdominal pain [modified Structured Assessment of GastroIntestinal Symptoms (SAGIS)] will be used. Clinically significantly abnormal findings will be reported as adverse events
Measured: Through study completion, up to 6 months
Secondary outcomes (3)
Gastric retention assessed by abdominal ultrasound (U/S)
Visualization of formulation/formulation components in the stomach by U/S
Measured: Up to 9 Days post-dosing
Confirm esophageal clearance of several MR capsules and a placebo capsule
For Group 1 and Group 2 via endoscopy
Measured: 2 hours post dosing
Physical Feature of Recovered Formulation Components
Record the physical features, e.g. number of polymeric arms (if separate) or if attached to the core, of formulation components recovered from collected fecal specimens
Measured: Through study completion up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start25 Jun 2018
- Primary completion15 Sep 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A total of 40 eligible subjects participate in the Dosing and Observation period. The enrollment occurs in five Dosing Groups. Within each Dosing Group, subjects are randomized to receive either one of four LYN-PLT extended release capsules or a placebo capsule (8 per formulation).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyndra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, MD, Principal investigator, CMAX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718390
- Sponsor's protocol ID
- LYN-PLT-C-001
- Other IDs
- ACTRN12618000991213, CM8818
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03718390
- Acronym / sponsor ID
- LYN-PLT-C-001
- Conditions
- Gastric Retention, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lyndra Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicentre, observer blind, randomised, single dose study in healthy adult subjects.
The first 5 subjects enrolled into the study will be regarded as Dosing Group 1 (sentinel group) and assigned to each of the five available study formulations. Dosing of subjects in Dosing Groups 1 and 2 will be performed at the endoscopy centre. Dosing of subjects in Dosing Groups 3 through 5 will be performed at the clinical site.
Subjects remain in the inpatient unit for 7 days after dosing. During this time, subjects undergo intermittent imaging assessments for gastric retention (MRI and abdominal U/S), safety assessments and faecal collections for assessments of retrieved components and bowel movement characteristics.
Subjects return to the clinic on Days 10, 15, 22 and 29 (End of Study visit). Safety assessments will be performed at all visits. MRI, abdominal U/S and outpatient faecal collections may continue based on the clinical findings from subjects dosed with modified release capsule formulations. On Day 29, the subjects will undergo final safety assessments at the clinic and thereafter, will be discharged from the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A total of 40 eligible subjects participate in the Dosing and Observation period. The enrollment occurs in five Dosing Groups. Within each Dosing Group, subjects are randomized to receive either one of four LYN-PLT extended release capsules or a placebo capsule (8 per formulation).
| Arm | Type | Receives |
|---|---|---|
| Sentinel Group 1 LYN-PLT | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Procedure: Endoscopy, Procedure: Magnetic Resonance ImagingSentinel 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 |
| Sentinel Group 2 LYN-PLT | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Procedure: Endoscopy, Procedure: Magnetic Resonance ImagingSentinel 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 |
| Group 3 LYN-PLT | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Procedure: Magnetic Resonance ImagingDosing 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 |
| Group 4 LYN-PLT | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Procedure: Magnetic Resonance ImagingDosing 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 |
| Group 5 LYN-PLT | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Procedure: Magnetic Resonance ImagingDosing 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation AAlso: LYN-PLT Formulation AFormulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation | Drug | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| Formulation BAlso: LYN-PLT Formulation BFormulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation | Drug | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| Formulation CAlso: LYN-PLT Formulation CFormulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation | Drug | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| Formulation DAlso: LYN-PLT Formulation DFormulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation | Drug | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| Formulation EAlso: Placebo capsulePlacebo Capsule containing microcrystalline cellulose | Drug | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| EndoscopyEndoscopy at 2 hours post dosing | Procedure or surgery | Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
| Magnetic Resonance ImagingAlso: MRIMRI will be performed on specified days according to protocol | Procedure or surgery | Group 3 LYN-PLT, Group 4 LYN-PLT, Group 5 LYN-PLT, Sentinel Group 1 LYN-PLT, Sentinel Group 2 LYN-PLT |
Primary outcome
Gastric retention assessed by Magnetic Resonance Imaging (MRI)
Time frame: Up to 9 Days post-dosing
Visualization of formulation/formulation components in the stomach by MRI
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports
Time frame: Through study completion, up to 6 months
The number of confirmed gastrointestinal adverse events will be reported based on spontaneous adverse event reporting
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)
Time frame: Through study completion, up to 6 months
Clinically significant aggregate changes in vital signs, physical examinations and safety laboratory assessments (haematology, liver function tests, clinical chemistry panel) between pre-dose (Day 1) and post-dosing (Day 4 and 7) will be reported as AE's
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
Time frame: Through study completion, up to 6 months
Examination and reporting of post-dosing bowel movements for blood; clinically significant abnormal findings will be reported as AE's.
Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting
Time frame: Through study completion, up to 6 months
If abdominal pain occurs, a systematic algorithm to evaluate abdominal pain [modified Structured Assessment of GastroIntestinal Symptoms (SAGIS)] will be used. Clinically significantly abnormal findings will be reported as adverse events
3 secondary outcomes
Gastric retention assessed by abdominal ultrasound (U/S)
Time frame: Up to 9 Days post-dosing
Confirm esophageal clearance of several MR capsules and a placebo capsule
Time frame: 2 hours post dosing
Physical Feature of Recovered Formulation Components
Time frame: Through study completion up to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sepehr Shakib, MD principal investigator
CMAX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Gastric Retention and Healthy, 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 10 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 assessed by Magnetic Resonance Imaging (MRI) (time frame: Up to 9 Days post-dosing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.