\[14C\]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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
Single oral dose
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, United Kingdom
Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.
Blood sampling
Time frame: Up to 168 hours post-dose
Peak plasma concentration of 14C labelled PRC-4016 (icosabutate)
Blood sampling
Time frame: Up to 168 hours post-dose
Quantifying urinary and faecal excretion of 14C labelled PRC-4016
Urine- and faecal collection
Time frame: Up to 168 hours post-dose
Number of participants with adverse events as a measure of safety and tolerability of a single dose oral 14C PRC-4016 (icosabutate)
Time frame: During entire study, screening till Day 8
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