NCT02373176

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: Male
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]PRC 4016 (Icosabutate)	Single oral dose

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2015-02-26
• Last updated: 2015-02-26

Locations

1 site across 1 country: United Kingdom