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

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.

Timeline

Start

2014-07

Primary completion

2014-09

Completion

2014-09

Drugs

Indications

No indication recorded.