[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.

[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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]PRC 4016 (Icosabutate)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Icosabutate

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Pronova BioPharma
• Investigators: Principal Investigator: Jim Bush, MD PhD, Covance Clinical Research Unit

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CTN401614102