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OpenTrials
Completed

NCT Number: NCT03718390

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

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Key information

Conditions

Gastric Retention Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CMAX

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formulation A

Drug

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

Other names: LYN-PLT Formulation A

Formulation B

Drug

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

Other names: LYN-PLT Formulation B

Formulation C

Drug

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

Other names: LYN-PLT Formulation C

Formulation D

Drug

Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation

Other names: LYN-PLT Formulation D

Formulation E

Drug

Placebo Capsule containing microcrystalline cellulose

Other names: Placebo capsule

endoscopy

Procedure

Endoscopy at 2 hours post dosing

Magnetic Resonance Imaging

Procedure

MRI will be performed on specified days according to protocol

Other names: MRI

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Lyndra Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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