[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
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|ClinicalTrials.gov Identifier: NCT02373176|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
[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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: [14C]PRC 4016 (Icosabutate)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: [14C] PRC-4016 (Icosabutate)
Investigational medicinal product (IMP), [14C] PRC-4016 (Icosabutate) solution (600 mg in 2 mL, 200.0 μCi [7.4 MBq]). The radiochemical purity of [14C]PRC-4016 will be at least 97%.
Drug: [14C]PRC 4016 (Icosabutate)
Single oral dose
Other Name: Icosabutate
- Area under curve for total 14C labelled PRC-4016 in whole blood and plasma. [ Time Frame: Up to 168 hours post-dose ]Blood sampling
- Peak plasma concentration of 14C labelled PRC-4016 (icosabutate) [ Time Frame: Up to 168 hours post-dose ]Blood sampling
- Quantifying urinary and faecal excretion of 14C labelled PRC-4016 [ Time Frame: Up to 168 hours post-dose ]Urine- and faecal collection
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373176
|Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street|
|Leeds, United Kingdom, LS2 9LH|
|Principal Investigator:||Jim Bush, MD PhD||Covance Clinical research Unit|