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

NCT02373176 | Completed Phase 1

• 1 other identifier: CTN401614102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (1)

[14C] PRC-4016 (Icosabutate)

EXPERIMENTAL

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)

Interventions

[14C]PRC 4016 (Icosabutate) DRUG

Single oral dose

Also known as: Icosabutate

[14C] PRC-4016 (Icosabutate)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males
• any ethnic origin
• age 35-60
• BMI 18-35 kg/m2
• generally in good health
• signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pronova BioPharma: lead

Study Sites (1)

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

icosabutate

Study Officials

• Jim Bush, MD PhD

  Covance Clinical research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 26, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

GB (1)