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

NCT03718390 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Gastric Retention
  • Healthy

Interventions

DRUG

Formulation A

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

DRUG

Formulation B

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

DRUG

Formulation C

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

DRUG

Formulation D

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

DRUG

Formulation E

Placebo Capsule containing microcrystalline cellulose

PROCEDURE

Endoscopy

Endoscopy at 2 hours post dosing

PROCEDURE

Magnetic Resonance Imaging

MRI will be performed on specified days according to protocol

Sponsors & Collaborators

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, MD · CMAX

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2018-09-15
Completion
2018-11-02

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718390 on ClinicalTrials.gov