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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373176
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Drug: [14C]PRC 4016 (Icosabutate) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: [14C] PRC-4016 (Icosabutate) - A Phase I, Open-label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: [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%.
Drug: [14C]PRC 4016 (Icosabutate)
Single oral dose
Other Name: Icosabutate




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373176


Locations
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United Kingdom
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Pronova BioPharma
Investigators
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Principal Investigator: Jim Bush, MD PhD Covance Clinical research Unit
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Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT02373176    
Other Study ID Numbers: CTN401614102
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015