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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373176
• Other study ID #: CTN401614102
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2015
• Last updated: February 20, 2015
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]PRC 4016 (Icosabutate)
Single oral dose

Locations

Country	Name	City	State
United Kingdom	Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

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