Clinical trial NCT02373176: [14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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* subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.

Primary outcomes:
measure: Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.
timeFrame: Up to 168 hours post-dose
measure: Peak plasma concentration of 14C labelled PRC-4016 (icosabutate)
timeFrame: Up to 168 hours post-dose
measure: Quantifying urinary and faecal excretion of 14C labelled PRC-4016
timeFrame: Up to 168 hours post-dose
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability of a single dose oral 14C PRC-4016 (icosabutate)
timeFrame: During entire study, screening till Day 8
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Study officials:
affiliation: Covance Clinical research Unit
name: Jim Bush, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: