- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718390
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Placebo Capsule containing microcrystalline cellulose
Other Names:
Endoscopy at 2 hours post dosing
MRI will be performed on specified days according to protocol
Other Names:
|
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
|
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Placebo Capsule containing microcrystalline cellulose
Other Names:
Endoscopy at 2 hours post dosing
MRI will be performed on specified days according to protocol
Other Names:
|
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
|
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Placebo Capsule containing microcrystalline cellulose
Other Names:
MRI will be performed on specified days according to protocol
Other Names:
|
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
|
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Placebo Capsule containing microcrystalline cellulose
Other Names:
MRI will be performed on specified days according to protocol
Other Names:
|
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.
|
Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
Other Names:
Placebo Capsule containing microcrystalline cellulose
Other Names:
MRI will be performed on specified days according to protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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)
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
|
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
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.
|
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
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
|
Through study completion, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric retention assessed by abdominal ultrasound (U/S)
Time Frame: Up to 9 Days post-dosing
|
Visualization of formulation/formulation components in the stomach by U/S
|
Up to 9 Days post-dosing
|
Confirm esophageal clearance of several MR capsules and a placebo capsule
Time Frame: 2 hours post dosing
|
For Group 1 and Group 2 via endoscopy
|
2 hours post dosing
|
Physical Feature of Recovered Formulation Components
Time Frame: Through study completion up to Day 29
|
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
|
Through study completion up to Day 29
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LYN-PLT-C-001
- ACTRN12618000991213 (Registry Identifier: ANZCTR)
- CM8818 (Other Identifier: CMAX)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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