Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults

Early Phase 1CompletedNCT03718390

Lyndra Inc.40 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Gastric Retention Healthy

Interventions

Formulation ADRUG

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

Formulation BDRUG

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

Formulation CDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CMAX

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Gastric retention assessed by Magnetic Resonance Imaging (MRI)

Visualization of formulation/formulation components in the stomach by MRI

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Through study completion, up to 6 months

Data from ClinicalTrials.gov

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Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes