Clinical trial NCT03718390: Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastric Retention
Healthy
Lead sponsor: Lyndra Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric retention assessed by Magnetic Resonance Imaging (MRI)
timeFrame: Up to 9 Days post-dosing
measure: Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting based on spontaneous reports
timeFrame: Through study completion, up to 6 months
measure: 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)
timeFrame: Through study completion, up to 6 months
measure: 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
timeFrame: Through study completion, up to 6 months
measure: Safety and tolerability of four LYN-PLT modified release capsules and a placebo capsule collected from Adverse Event (AE) reporting
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
measure: Gastric retention assessed by abdominal ultrasound (U/S)
timeFrame: Up to 9 Days post-dosing
measure: Confirm esophageal clearance of several MR capsules and a placebo capsule
timeFrame: 2 hours post dosing
measure: Physical Feature of Recovered Formulation Components
timeFrame: Through study completion up to Day 29
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: CMAX
name: Sepehr Shakib, MD
role: PRINCIPAL_INVESTIGATOR
References: