Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults
Condition: Gastric Retention; Healthy
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Formulation A; Formulation B; Formulation C; Formulation D; Formulation E; Endoscopy; Magnetic Resonance Imaging
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation; Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation; Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation; Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation; Placebo Capsule containing microcrystalline cellulose; Endoscopy at 2 hours post dosing; MRI will be performed on specified days according to protocol
Other intervention name(s): LYN-PLT Formulation A; LYN-PLT Formulation B; LYN-PLT Formulation C; LYN-PLT Formulation D; Placebo capsule; MRI
Allocation: Randomized
Intervention model: Factorial Assignment
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).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science