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

2019-12-05 00:03:17 | BioPortfolio

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.

Study Design

Conditions

Pharmacokinetics

Intervention

PXS-5382A

Status

Not yet recruiting

Source

Pharmaxis

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-05T00:03:17-0500

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Medical and Biotech [MESH] Definitions

Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.

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