HealthyPhase 1NCT02364635
Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
A Phase 1 study testing icosabutate in people with Healthy, run by Pronova BioPharma at 1 site in United Kingdom.
Trial summary
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects Objective: To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects To evaluate the pharmacokinetic (PK) parameters… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- icosabutate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Aug 2015
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males of females
- any ethnic origin
- Age 18-55 years
- BMI 18.0 - 33.0 kg/m2
- generally in good health
- signed informed consent
Who cannot join
- males or females not willing to use appropriate contraception
- recent blood donation
- recent blood received
- high consumption of alcohol
- high consumption of tobacco
- subjects who have engaged in heavy exercise last two weeks
Show all 12Show fewer
- prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
- other medication know to alter drug absorption or elimination
- abnormal heart rate or blood pressure or 12-lead ECG
- significant history of drug allergy, or hypersensitivity to treatment ingredients
- ocular disorder requiring topical ocular therapy, or recent allergic eye disease
- other significant medical history or physical findings
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd.
Leeds, LS2 9LH
About this study
Official title: PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Objective:
- To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
- To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
- Conditions
- Healthy
- Being tested
- icosabutate
- Keywords
- Phase I pharmacokinetics and safety study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icosabutateDrug
Also called PRC-4016
Single dose at each dose levet
| Study group | Role | What they receive |
|---|---|---|
| Icosabutate dose 1 | Experimental | Dose 1 Receives: Drug: icosabutate |
| Icosabutate dose 2 | Experimental | Dose 2 Receives: Drug: icosabutate |
| Icosabutate dose 3 | Experimental | Dose 3 Receives: Drug: icosabutate |
| Placebo | Placebo comparator | Placebo (medium chain triglycerides) Receives: Drug: icosabutate |
| Icosabutate dose 4 | Experimental | Dose 4 Receives: Drug: icosabutate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessments of icosabutate - AUC
Exposure level of icosabutate measured as Area Under the Curve (AUC)
Measured: 0-36 hour
Pharmacokinetic assessments of icosabutate - Cmax
Maximum observed plasma concentration of icosabutate (Cmax)
Measured: 0-36 hour
Number of patients with Adverse Events
Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained
Measured: During the 36 hour assessment, and at post-study visit day 5-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Brooks, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364635
- Sponsor's protocol ID
- CTN401614104
- Status last verified
- Sep 2015
- First submitted
- 22 Jan 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02364635
- Acronym / sponsor ID
- CTN401614104
- Conditions
- Healthy
- Keywords
- Phase I pharmacokinetics and safety study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 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.
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Objective:
- To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
- To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Icosabutate dose 1 | Experimental | Drug: icosabutateDose 1 |
| Icosabutate dose 2 | Experimental | Drug: icosabutateDose 2 |
| Icosabutate dose 3 | Experimental | Drug: icosabutateDose 3 |
| Placebo | Placebo comparator | Drug: icosabutatePlacebo (medium chain triglycerides) |
| Icosabutate dose 4 | Experimental | Drug: icosabutateDose 4 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- males of females
- any ethnic origin
- Age 18-55 years
- BMI 18.0 - 33.0 kg/m2
- generally in good health
Key exclusion criteria (12 listed)
- males or females not willing to use appropriate contraception
- recent blood donation
- recent blood received
- high consumption of alcohol
- high consumption of tobacco
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 |
|---|---|---|
| icosabutateAlso: PRC-4016Single dose at each dose levet | Drug | Icosabutate dose 1, Icosabutate dose 2, Icosabutate dose 3, Icosabutate dose 4, Placebo |
Primary outcome
Pharmacokinetic assessments of icosabutate - AUC
Time frame: 0-36 hour
Exposure level of icosabutate measured as Area Under the Curve (AUC)
Pharmacokinetic assessments of icosabutate - Cmax
Time frame: 0-36 hour
Maximum observed plasma concentration of icosabutate (Cmax)
Number of patients with Adverse Events
Time frame: During the 36 hour assessment, and at post-study visit day 5-7
Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained
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 29 Sep 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.
Ashley Brooks, MD principal investigator
Covance
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 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 12 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 29 Sep 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetic assessments of icosabutate - AUC (time frame: 0-36 hour). 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 29 Sep 2015.