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A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects

Healthy Clinical Trial

Official title:
A Phase 1, Open-Label Study to Assess the Single Dose Pharmacokinetics of Suspension and Capsule Formulations of SR419 and Repeat Dose Pharmacokinetics of Capsule Formulation of SR419, and to Assess the Effect of a High-Fat Meal on the Pharmacokinetics of SR419 in Healthy Subjects

Clinical Trial Summary

This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.

Clinical Trial Description

This study is a phase 1, open-label study to assess the single dose pharmacokinetics of suspension and capsule formulations of SR419 and repeat dose pharmacokinetics of capsule formulation of SR419, and to assess the effect of a high-fat meal on the pharmacokinetics of SR419 in healthy subjects.The trial will consist of 3 cohorts. Cohort 1 and 2 will follow a single sequence, 3-period, 2-formulation, dosing in fasted or fed state design. Cohort 3 will be a repeated dose study of SR419 capsule in healthy subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04705077
Study type Interventional
Source SIMR (Australia) Biotech Pty Ltd
Contact
Status Completed
Phase Phase 1
Start date February 2, 2021
Completion date March 12, 2021
View Details
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