AllergyPhase 1NCT02316912
First in Man Evaluation of Single and Multiple Doses of Oral ATX2417
A Phase 1 study testing ATX2417 in people with Allergy, run by Atopix Therapeutics, Ltd. at 1 site in United Kingdom.
Trial summary
First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- ATX2417
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Apr 2016
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, any racial group
- Able to comply with the protocol
- Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
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 dose of study drug 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research
Merthyr Tydfil, Glamorgan, CF48 4DR
About this study
Official title: Double Blind Randomised Placebo Controlled Evaluation of Single and Multiple Oral Doses of ATX2417 in Man and Effect of Food
First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.
Read the detailed description
The study consists of two parts, A (single ascending dose including fasted/fed comparison) and B (multiple ascending dose). Part B will be conducted after a thorough review by the Sponsor and the Principal Investigator of the data arising from part A.
Part A This will be a randomised, double blind, placebo controlled, parallel group titration of up to seven single dose levels of ATX2417. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. At each dose level, 2 subjects (1 subject will receive ATX2417 and 1 subject will receive placebo) will be dosed on Day 1 and the remaining 6 subjects will be dosed at least 24 hours later. Safety and pharmacokinetic observations will be made. There will be a minimum of two weeks between the first dosing day at each dose level. Safety and ATX2417 pharmacokinetic data will be reviewed prior to each dose escalation and, based on pharmacokinetic data, it is also possible to decrease the dose if the pharmacokinetic profile so indicates. This part will also include an assessment of the effect of a high fat breakfast on the absorption and pharmacokinetic profile of ATX 2417, performed at a dose predicted to be associated with therapeutic plasma concentrations.
Part B Following completion of Part A, and selection of appropriate dose levels, Part B will be performed. This will be a randomised, double blind, placebo controlled, parallel group study of up to two dose levels of ATX2417 given once daily for eight days. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. Safety and pharmacokinetic observations will be made.
- Conditions
- Allergy
- Being tested
- ATX2417, Placebo
- Keywords
- allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX2417Drug
Randomised double blind parallel group ascending dose assessment
PlaceboDrug
Randomised double blind parallel group ascending dose assessment
| Study group | Role | What they receive |
|---|---|---|
| Single dose level 1 active | Active comparator | Six subjects ATX2417 I mg tablet once. Receives: Drug: ATX2417 |
| Single dose level 2 active | Active comparator | Six subjects ATX2417 2x1 mg tablet once. Receives: Drug: ATX2417 |
| Single dose level 3 active | Active comparator | Six subjects ATX2417 5 mg tablet once. Receives: Drug: ATX2417 |
| Single dose level 4 active | Active comparator | Six subjects ATX2417 4x5 mg tablets once. Receives: Drug: ATX2417 |
| Single dose level 5 active | Active comparator | Six subjects ATX2417 to be determined. Receives: Drug: ATX2417 |
| Multiple dose level 1 active | Active comparator | Six subjects ATX2417 dose to be determined once daily for 8 days. Receives: Drug: ATX2417 |
| Multiple dose level 2 active | Active comparator | Six subjects ATX2417 dose to be determined once daily for 8 days. Receives: Drug: ATX2417 |
| Single dose level 1 placebo | Placebo comparator | Two subjects one placebo tablet once. Receives: Drug: Placebo |
| Single dose level 2 placebo | Placebo comparator | Two subjects one placebo tablet x2 once. Receives: Drug: Placebo |
| Single dose level 3 placebo | Placebo comparator | Two subjects one placebo tablet once. Receives: Drug: Placebo |
| Single dose level 4 placebo | Placebo comparator | Two subjects two placebo tablets once. Receives: Drug: Placebo |
| Single dose level 5 placebo | Placebo comparator | Two subjects four placebo tablets once. Receives: Drug: Placebo |
| Multiple dose level 1 placebo | Placebo comparator | Two subjects matching placebo(s) once daily for 8 days Receives: Drug: Placebo |
| Multiple dose level 2 placebo | Placebo comparator | Two subjects matching placebo(s) once daily for 8 days. Receives: Drug: Placebo |
| Single dose level 6 active | Active comparator | Six subjects ATX2417 to be determined. Receives: Drug: ATX2417 |
| Single dose level 7 active | Active comparator | Six subjects ATX2417 to be determined. Receives: Drug: ATX2417 |
| Single dose level 6 placebo | Placebo comparator | Six subjects placeboto be determined. Receives: Drug: Placebo |
| Single dose level 7 placebo | Placebo comparator | Six subjects placebo to be determined. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability
Number of subjects with adverse events
Measured: 120 hours after dosing
Secondary outcomes (2)
AUC0-t
Area under concentration time curve at 120 hours
Measured: 120 hours after single dose
AUC0-t
Area under concentration time curve at 120 hours
Measured: 120 hours after eighth dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atopix Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Khalid Abou Farha, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316912
- Sponsor's protocol ID
- ATX2417/001/14
- Status last verified
- Jul 2016
- First submitted
- 2 Dec 2014
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomised Placebo Controlled Evaluation of Single and Multiple Oral Doses of ATX2417 in Man and Effect of Food
- ClinicalTrials.gov ID
- NCT02316912
- Acronym / sponsor ID
- ATX2417/001/14
- Conditions
- Allergy
- Keywords
- allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Atopix Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Dec 2014 (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.
First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.
Detailed description
The study consists of two parts, A (single ascending dose including fasted/fed comparison) and B (multiple ascending dose). Part B will be conducted after a thorough review by the Sponsor and the Principal Investigator of the data arising from part A.
Part A This will be a randomised, double blind, placebo controlled, parallel group titration of up to seven single dose levels of ATX2417. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. At each dose level, 2 subjects (1 subject will receive ATX2417 and 1 subject will receive placebo) will be dosed on Day 1 and the remaining 6 subjects will be dosed at least 24 hours later. Safety and pharmacokinetic observations will be made. There will be a minimum of two weeks between the first dosing day at each dose level. Safety and ATX2417 pharmacokinetic data will be reviewed prior to each dose escalation and, based on pharmacokinetic data, it is also possible to decrease the dose if the pharmacokinetic profile so indicates. This part will also include an assessment of the effect of a high fat breakfast on the absorption and pharmacokinetic profile of ATX 2417, performed at a dose predicted to be associated with therapeutic plasma concentrations.
Part B Following completion of Part A, and selection of appropriate dose levels, Part B will be performed. This will be a randomised, double blind, placebo controlled, parallel group study of up to two dose levels of ATX2417 given once daily for eight days. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. Safety and pharmacokinetic observations will be made.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Single dose level 1 active | Active comparator | Drug: ATX2417Six subjects ATX2417 I mg tablet once. |
| Single dose level 2 active | Active comparator | Drug: ATX2417Six subjects ATX2417 2x1 mg tablet once. |
| Single dose level 3 active | Active comparator | Drug: ATX2417Six subjects ATX2417 5 mg tablet once. |
| Single dose level 4 active | Active comparator | Drug: ATX2417Six subjects ATX2417 4x5 mg tablets once. |
| Single dose level 5 active | Active comparator | Drug: ATX2417Six subjects ATX2417 to be determined. |
| Multiple dose level 1 active | Active comparator | Drug: ATX2417Six subjects ATX2417 dose to be determined once daily for 8 days. |
| Multiple dose level 2 active | Active comparator | Drug: ATX2417Six subjects ATX2417 dose to be determined once daily for 8 days. |
| Single dose level 1 placebo | Placebo comparator | Drug: PlaceboTwo subjects one placebo tablet once. |
| Single dose level 2 placebo | Placebo comparator | Drug: PlaceboTwo subjects one placebo tablet x2 once. |
| Single dose level 3 placebo | Placebo comparator | Drug: PlaceboTwo subjects one placebo tablet once. |
| Single dose level 4 placebo | Placebo comparator | Drug: PlaceboTwo subjects two placebo tablets once. |
| Single dose level 5 placebo | Placebo comparator | Drug: PlaceboTwo subjects four placebo tablets once. |
| Multiple dose level 1 placebo | Placebo comparator | Drug: PlaceboTwo subjects matching placebo(s) once daily for 8 days |
| Multiple dose level 2 placebo | Placebo comparator | Drug: PlaceboTwo subjects matching placebo(s) once daily for 8 days. |
| Single dose level 6 active | Active comparator | Drug: ATX2417Six subjects ATX2417 to be determined. |
| Single dose level 7 active | Active comparator | Drug: ATX2417Six subjects ATX2417 to be determined. |
| Single dose level 6 placebo | Placebo comparator | Drug: PlaceboSix subjects placeboto be determined. |
| Single dose level 7 placebo | Placebo comparator | Drug: PlaceboSix subjects placebo to be determined. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects, any racial group
- Able to comply with the protocol
- Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
Key exclusion criteria (5 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 dose of study drug 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 |
|---|---|---|
| ATX2417Randomised double blind parallel group ascending dose assessment | Drug | Multiple dose level 1 active, Multiple dose level 2 active, Single dose level 1 active, Single dose level 2 active, Single dose level 3 active, Single dose level 4 active, Single dose level 5 active, Single dose level 6 active, Single dose level 7 active |
| PlaceboRandomised double blind parallel group ascending dose assessment | Drug | Multiple dose level 1 placebo, Multiple dose level 2 placebo, Single dose level 1 placebo, Single dose level 2 placebo, Single dose level 3 placebo, Single dose level 4 placebo, Single dose level 5 placebo, Single dose level 6 placebo, Single dose level 7 placebo |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: 120 hours after dosing
Number of subjects with adverse events
2 secondary outcomes
AUC0-t
Time frame: 120 hours after single dose
AUC0-t
Time frame: 120 hours after eighth dose
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 19 Jul 2016.
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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.
Khalid Abou Farha, 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 ATX2417 in people with Allergy, 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 3 inclusion and 5 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 19 Jul 2016. 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?
Number of subjects with adverse events as a measure of safety and tolerability (time frame: 120 hours after dosing). 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 19 Jul 2016.