AsthmaPhase 1NCT02341521
Evaluation of Metabolic Profile of OC000459
A Phase 1 study testing OC000459 in people with Asthma, run by Atopix Therapeutics, Ltd. at 1 site in United Kingdom.
Trial summary
An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics of parent compound and metabolite after eight days of dosing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- OC000459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to May 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
- Healthy male and female subjects, any racial group
- Aged 18-55 years inclusive
- Able to comply with the protocol
- Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 21 days of the first dose
Who cannot join
- A history of gastrointestinal disorder likely to influence drug absorption
- Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day with the exception of paracetamol up to a maximum of 2 g daily
- Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
- A history of drug or alcohol abuse
- Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)
- Participation in a clinical study within 3 months of the first dose of study drug. Subjects will be checked against The Over Volunteering Prevention System (TOPS)
Show all 9Show fewer
- Donation of 450 mL or more blood within 60 days of the first dose of study drug
- A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Plasma and Urine Pharmacokinetics of Parent Compound and a Metabolite of OC000459 in Healthy Male and Female Subjects
An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics of parent compound and metabolite after eight days of dosing.
Read the detailed description
The study will include 9 male and 9 female healthy subjects. Following informed consent and satisfactory screening, each will be dosed for seven consecutive days on an outpatient basis with OC000459 50 mg daily taken before breakfast. On the seventh day, subjects will report to the clinical unit. Following an overnight fast, blood samples will be drawn for baseline safety and pharmacokinetic measurements and a urine specimen will be obtained for urinalysis and baseline metabolite measurements and subjects will be dosed with 50 mg OC000459. Blood samples will then be drawn at selected intervals for 120 hours post dosing and will be analysed for OC000459 parent compound and its metabolite. Urine collections will be obtained over the same period to determine the excretion of the metabolite and parent compound in urine.
- Conditions
- Asthma
- Being tested
- OC000459
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC000459Drug
Taken orally for 8 days
| Study group | Role | What they receive |
|---|---|---|
| OC000459 50 mg | Experimental | OC000459 50 mg daily for 8 days Receives: Drug: OC000459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite
Metabolite AUC
Measured: Day 8
Secondary outcomes (1)
Parent compound
Parent compound AUC
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atopix Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341521
- Sponsor's protocol ID
- OC000459/018/14
- Status last verified
- Mar 2015
- First submitted
- 14 Jan 2015
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Plasma and Urine Pharmacokinetics of Parent Compound and a Metabolite of OC000459 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02341521
- Acronym / sponsor ID
- OC000459/018/14
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Atopix Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Jan 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.
An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics of parent compound and metabolite after eight days of dosing.
Detailed description
The study will include 9 male and 9 female healthy subjects. Following informed consent and satisfactory screening, each will be dosed for seven consecutive days on an outpatient basis with OC000459 50 mg daily taken before breakfast. On the seventh day, subjects will report to the clinical unit. Following an overnight fast, blood samples will be drawn for baseline safety and pharmacokinetic measurements and a urine specimen will be obtained for urinalysis and baseline metabolite measurements and subjects will be dosed with 50 mg OC000459. Blood samples will then be drawn at selected intervals for 120 hours post dosing and will be analysed for OC000459 parent compound and its metabolite. Urine collections will be obtained over the same period to determine the excretion of the metabolite and parent compound in urine.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OC000459 50 mg | Experimental | Drug: OC000459OC000459 50 mg daily for 8 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects, any racial group
- Aged 18-55 years inclusive
- Able to comply with the protocol
- Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 21 days of the first dose
Key exclusion criteria (9 listed)
- A history of gastrointestinal disorder likely to influence drug absorption
- Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day with the exception of paracetamol up to a maximum of 2 g daily
- Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
- A history of drug or alcohol abuse
- Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)
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 |
|---|---|---|
| OC000459Taken orally for 8 days | Drug | OC000459 50 mg |
Primary outcome
Metabolite
Time frame: Day 8
Metabolite AUC
1 secondary outcome
Parent compound
Time frame: 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 25 May 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.
Salvatore Febbraro, MD principal investigator
Simbec Research
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 OC000459 in people with Asthma, run by Atopix Therapeutics, Ltd. 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 5 inclusion and 9 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 25 May 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?
Metabolite (time frame: Day 8). 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 25 May 2015.