HealthyPhase 1NCT02373176
[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
A Phase 1 study testing [14C]PRC 4016 (Icosabutate) in people with Healthy, run by Pronova BioPharma at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]PRC 4016 (Icosabutate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males
- any ethnic origin
- age 35-60
- BMI 18-35 kg/m2
- generally in good health
- signed informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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- subjects earlier taken part in the study or withdrawn from study ot not suitable for enrolment according to investigator.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, LS2 9LH
About this study
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.
[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.
- Conditions
- Healthy
- Being tested
- [14C]PRC 4016 (Icosabutate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]PRC 4016 (Icosabutate)Drug
Also called Icosabutate
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| [14C] PRC-4016 (Icosabutate) | Experimental | 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%. Receives: Drug: [14C]PRC 4016 (Icosabutate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve for total 14C labelled PRC-4016 in whole blood and plasma.
Blood sampling
Measured: Up to 168 hours post-dose
Peak plasma concentration of 14C labelled PRC-4016 (icosabutate)
Blood sampling
Measured: Up to 168 hours post-dose
Quantifying urinary and faecal excretion of 14C labelled PRC-4016
Urine- and faecal collection
Measured: Up to 168 hours post-dose
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)
Measured: During entire study, screening till Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MD PhD, Principal investigator, Covance Clinical research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373176
- Sponsor's protocol ID
- CTN401614102
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02373176
- Acronym / sponsor ID
- CTN401614102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] PRC-4016 (Icosabutate) | Experimental | Drug: [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%. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- males
- any ethnic origin
- age 35-60
- BMI 18-35 kg/m2
- generally in good health
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]PRC 4016 (Icosabutate)Also: IcosabutateSingle oral dose | Drug | [14C] PRC-4016 (Icosabutate) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Bush, MD PhD principal investigator
Covance Clinical research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]PRC 4016 (Icosabutate) in people with Healthy, run by Pronova BioPharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve for total 14C labelled PRC-4016 in whole blood and plasma. (time frame: Up to 168 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.