[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
- Conditions
- Healthy
- Interventions
- Drug: [14C]PRC 4016 (Icosabutate)
- Registration Number
- NCT02373176
- Lead Sponsor
- Pronova BioPharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- males
- any ethnic origin
- age 35-60
- BMI 18-35 kg/m2
- generally in good health
- signed informed consent
- 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- subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C] PRC-4016 (Icosabutate) [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%.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
🇬🇧Leeds, United Kingdom
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street🇬🇧Leeds, United Kingdom