Healthy Clinical Trial
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
Verified date | February 2019 |
Source | Lyndra Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
Australia | CMAX | Adelaide | South Australia |
Lead Sponsor | Collaborator |
---|---|
Lyndra Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric retention assessed by Magnetic Resonance Imaging (MRI) | Visualization of formulation/formulation components in the stomach by MRI | Up to 9 Days post-dosing | |
Primary | 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 | Through study completion, up to 6 months | |
Primary | 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 | Through study completion, up to 6 months | |
Primary | 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. | Through study completion, up to 6 months | |
Primary | 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 | Through study completion, up to 6 months | |
Secondary | Gastric retention assessed by abdominal ultrasound (U/S) | Visualization of formulation/formulation components in the stomach by U/S | Up to 9 Days post-dosing | |
Secondary | Confirm esophageal clearance of several MR capsules and a placebo capsule | For Group 1 and Group 2 via endoscopy | 2 hours post dosing | |
Secondary | 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 | Through study completion up to Day 29 |
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