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

NCT ID: NCT02373176

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

[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%.

Group Type: EXPERIMENTAL

[14C]PRC 4016 (Icosabutate)

Intervention Type: DRUG

Single oral dose

Interventions

[14C]PRC 4016 (Icosabutate)

Single oral dose

Intervention Type: DRUG

Other Intervention Names

Icosabutate

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pronova BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Bush, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical research Unit

Locations

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

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

CTN401614102

Identifier Type: -

Identifier Source: org_study_id