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

Phase 1
Completed
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
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  • subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
[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
NameTimeMethod
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-4016Up to 168 hours post-dose

Urine- and faecal collection

Secondary Outcome Measures
NameTimeMethod
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
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