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[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study

Healthy Clinical Trial

Official title:
[14C] PRC-4016 (Icosabutate) - A Phase I, Open-label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.

Clinical Trial Summary

[14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.

Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of [14C]PRC-4016 to healthy male subjects.

To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal excretion of radioactivity.

To examine the profile of metabolites in plasma, urine and faeces. To further assess the safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02373176
Study type Interventional
Source Pronova BioPharma
Contact
Status Completed
Phase Phase 1
Start date July 2014
Completion date September 2014
View Details
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