NCT03718390View on ClinicalTrials.gov

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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 25, 2018

Primary Completion Date

September 15, 2018

Study Completion Date

November 2, 2018

Conditions
Gastric RetentionHealthy
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

Trial Locations (1)

5000

CMAX, Adelaide

All Listed Sponsors
lead

Lyndra Inc.

INDUSTRY

NCT03718390 - Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults | Biotech Hunter | Biotech Hunter