[14C] PRC-4016 (Icosabutate) - A Phase I, Open-label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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- •subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.
Arms & Interventions
[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%.
Intervention: [14C]PRC 4016 (Icosabutate) (Drug)
Outcomes
Primary Outcomes
Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.
Time Frame: Up to 168 hours post-dose
Blood sampling
Peak plasma concentration of 14C labelled PRC-4016 (icosabutate)
Time Frame: Up to 168 hours post-dose
Blood sampling
Quantifying urinary and faecal excretion of 14C labelled PRC-4016
Time Frame: Up to 168 hours post-dose
Urine- and faecal collection
Secondary Outcomes
- 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)