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

NCT04183517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-06-25

No results posted yet for this study

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

DRUG

PXS-5382A

Orally once daily or twice daily

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Angela Molga, MBBS · CMAX Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2020-04-04
Completion
2020-06-24

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 NCT04183517 on ClinicalTrials.gov