NCT04183517

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Syntara · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	PXS-5382A	Orally once daily or twice daily

Timeline

• Start date: 2019-12-20
• Primary completion: 2020-04-04
• Completion: 2020-06-24
• First posted: 2019-12-03
• Last updated: 2020-06-25

Locations

1 site across 1 country: Australia