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

Pronova

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C]PRC 4016 (Icosabutate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02373176

CTN401614102

Details and patient eligibility

About

[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.

Enrollment: 6 patients

Sex: Male

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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• subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.

Trial design

6 participants in 1 patient group

[14C] PRC-4016 (Icosabutate)

Experimental group

Description:

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%.

Treatment:

Drug: [14C]PRC 4016 (Icosabutate)