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

Study Overview
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Brief Summary
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[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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]PRC 4016 (Icosabutate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males any ethnic origin age 35-60 BMI 18-35 kg/m2 generally in good health signed informed consent Exclusion Criteria: subjects or subjects partners not willing to use appropriate contraception subjects who have received prescribed systemic or topical medication within 14 days of dosing subjects who have used non-prescribed systemic or topical medication within 7 days of dosing subjects who have received any medication incl. St. Johns Worth within 30 days of dose administration. subjects participating in clinical trial currently or within past 3 months. recent blood donation history of drug allergy or clinically significant allergic disease BP and pulse outside reference range high consumption of alcohol high consumption og tobacco clinically significant disorder or clinically significant disease within 4 weeks of dosing. serum hepatitis, HIV or abnormal ECG subjects exposed to radiation as a result of their occupation subjects who have received radiolabelled material within 12 months subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C] PRC-4016 (Icosabutate)<br>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)<br>* Single oral dose<br>* Other names: Icosabutate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve for total 14C labelled PRC-4016 in whole blood and plasma. | Blood sampling | Up to 168 hours post-dose | 
| Peak plasma concentration of 14C labelled PRC-4016 (icosabutate) | Blood sampling | Up to 168 hours post-dose | 
| Quantifying urinary and faecal excretion of 14C labelled PRC-4016 | Urine- and faecal collection | Up to 168 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability of a single dose oral 14C PRC-4016 (icosabutate) |  | During entire study, screening till Day 8 |