Healthy
Conditions
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.
Interventions
DRUG[14C]PRC 4016 (Icosabutate)
Single oral dose
Sponsors
Pronova BioPharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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* subjects who have received radiolabelled material within 12 months * subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under curve for total 14C labelled PRC-4016 in whole blood and plasma. | Up to 168 hours post-dose | Blood sampling |
| Peak plasma concentration of 14C labelled PRC-4016 (icosabutate) | Up to 168 hours post-dose | Blood sampling |
| Quantifying urinary and faecal excretion of 14C labelled PRC-4016 | Up to 168 hours post-dose | Urine- and faecal collection |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed