A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males

Status Completed

Clinical Trial Summary

This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B.

For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Each subject during participation in the study will receive a dose of PXS 5382A orally in a fed state and a fasted state.

For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state and dose will be dependent on analysis of Part A.

In both part A and B PK, PD and safety assessments will be collected.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Pharmacokinetics

Clinical Trial Details

NCT number	NCT04183517
Study type	Interventional
Source	Pharmaxis
Contact
Status	Completed
Phase	Phase 1
Start date	December 20, 2019
Completion date	June 24, 2020

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