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Completed

NCT Number: NCT02373176

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

[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.

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Key information

Conditions

Healthy

Age range

35 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.

Treatment and study plan

[14C]PRC 4016 (Icosabutate)

Drug

Single oral dose

Other names: Icosabutate

Primary outcomes

  1. Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.

    Time frame: Up to 168 hours post-dose

    Blood sampling

  2. Peak plasma concentration of 14C labelled PRC-4016 (icosabutate)

    Time frame: Up to 168 hours post-dose

    Blood sampling

  3. Quantifying urinary and faecal excretion of 14C labelled PRC-4016

    Time frame: Up to 168 hours post-dose

    Urine- and faecal collection

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability of a single dose oral 14C PRC-4016 (icosabutate)

    Time frame: During entire study, screening till Day 8

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Registry information

Official study title

[14C] PRC-4016 (Icosabutate) - A Phase I, Open-label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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