PainPhase 1NCT02929264
An fMRI Study in Healthy Volunteers to Investigate the Effects of ABX-1431 on Experimental Hyperalgesia and Its Neural Correlates
A Phase 1 study testing ABX-1431 in people with Pain, run by Abide Therapeutics at 1 site in United Kingdom.
Trial summary
An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental hyperalgesia and its neural correlates. 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
- Pain
- What is being tested?
- ABX-1431
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Mar 2018
- 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
- Understands the study procedures and is willing and able to give informed consent for participation in the trial.
- Male, right-handed, aged 18 to 55 years of age at the first visit.
- Body mass index >18 and ≤30 kg/m2 at the first visit.
- Judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests (see appendix A for interpretation of laboratory findings) obtained at the first visit.
- No clinically significant abnormality of ECG performed on the first visit.
- Is a non-smoker and has not used nicotine or nicotine-containing products for at least 3 months.
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- In the Investigator's opinion, participant is able and willing to comply with all trial requirements.
- Willing to allow his or her General Practitioner to be notified of participation in the trial and to confirm the eligibility of the participant.
- Able to tolerate MRI scanning at the first visit. Responds to topical capsaicin by attaining a pain score of at least 4/10, assessed on the first visit.
Who cannot join
- A current acute pain condition.
- A personal history of a chronic pain condition.
- Contraindications to MRI scanning.
- Scheduled elective surgery or other procedures requiring general anesthesia during the trial.
- A personal history of a clinically significant psychiatric disorder (including severe affective disorder, anxiety disorders, psychotic tendencies and drug-induced psychoses). Subjects who have had situational depression in the past may be enrolled at the discretion of the investigator.
- A first-degree family history of schizophrenia, major affective disorder, or other psychosis.
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- Participant is mentally or legally incapacitated, has significant emotional problems at the time of the first visit, or is expected to have potential for mental incapacitation during the conduct of the study.
- A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by virtue of their participation in the study.
- An estimated creatinine clearance of ≤80ml/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as measured using a 24-hour urine collection, may be used in place of, or in conjunction with the Cockcraft-Gault calculation. Subjects with an actual or calculated creatinine clearance that is in the range of 72-79 mL/min (i.e., within 10% of 80 mL/min) may be enrolled in the study at the discretion of the Investigator.
- A history of stroke, chronic seizures, or major neurological disorder.
- A history of clinically significant (in the opinion of the investigator) endocrine, gastrointestinal, cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Participants with history of uncomplicated kidney stones (defined as spontaneous passage and no recurrence in the last 5 years) or childhood asthma may be enrolled in the trial at the discretion of the investigator.
- A history of clinically significant neoplastic disease, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin.
- A history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs (including capsaicin and marijuana or other cannabis-containing drugs) or food.
- Participants who have had major surgery or have donated or lost 1 unit (approximately 500ml) of blood within 4 weeks prior to the first visit.
Trial locations and contacts
1 site in 1 country.
About this study
An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental hyperalgesia and its neural correlates.
- Conditions
- Pain
- Being tested
- ABX-1431, Placebo
- Keywords
- Healthy volunteer, Experimental hyperalgesia, fMRI
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-1431Drug
Capsules, 40 mg, single dose
PlaceboDrug
Capsules, single dose
| Study group | Role | What they receive |
|---|---|---|
| ABX-1431 | Experimental | ABX-1431, capsules, 40 mg, single dose Receives: Drug: ABX-1431 |
| Placebo | Placebo comparator | Placebo, capsules, single dose Receives: Drug: Placebo |
| Control | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity in response to noxious stimuli, as assessed by fMRI, following a single dose of ABX-1431, compared to the same outcome following placebo and no treatment interventions.
Measured: Approximately 5 weeks
Secondary outcomes (2)
Pain scores, assessed by VAS for ongoing and evoked pain, recorded after sensitization with topical 1% capsaicin. Pain scores following single oral doses of ABX-1431 will be compared to those following placebo and no treatment.
Measured: Approximately 5 weeks
Severity of, and Number of Participants With Clinical and Laboratory Adverse Events (AE) following single oral doses of ABX-1431, placebo and no treatment as a Measure of Safety and Tolerability.
Measured: Approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abide Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Irene Tracey, DPhil., FRCA, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929264
- Sponsor's protocol ID
- ABX-1431_PN003
- Status last verified
- Mar 2018
- First submitted
- 3 Oct 2016
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An fMRI Study in Healthy Volunteers to Investigate the Effects of ABX-1431 on Experimental Hyperalgesia and Its Neural Correlates
- ClinicalTrials.gov ID
- NCT02929264
- Acronym / sponsor ID
- ABX-1431_PN003
- Conditions
- Pain
- Keywords
- Healthy volunteer, Experimental hyperalgesia, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abide TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Oct 2016 (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 fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental hyperalgesia and its neural correlates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABX-1431 | Experimental | Drug: ABX-1431ABX-1431, capsules, 40 mg, single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, capsules, single dose |
| Control | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Understands the study procedures and is willing and able to give informed consent for participation in the trial.
- Male, right-handed, aged 18 to 55 years of age at the first visit.
- Body mass index >18 and ≤30 kg/m2 at the first visit.
- Judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests (see appendix A for interpretation of laboratory findings) obtained at the first visit.
- No clinically significant abnormality of ECG performed on the first visit.
Key exclusion criteria (14 listed)
- A current acute pain condition.
- A personal history of a chronic pain condition.
- Contraindications to MRI scanning.
- Scheduled elective surgery or other procedures requiring general anesthesia during the trial.
- A personal history of a clinically significant psychiatric disorder (including severe affective disorder, anxiety disorders, psychotic tendencies and drug-induced psychoses). Subjects who have had situational depression in the past may be enrolled at the discretion of the investigator.
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 |
|---|---|---|
| ABX-1431Capsules, 40 mg, single dose | Drug | ABX-1431 |
| PlaceboCapsules, single dose | Drug | Placebo |
Primary outcome
Brain activity in response to noxious stimuli, as assessed by fMRI, following a single dose of ABX-1431, compared to the same outcome following placebo and no treatment interventions.
Time frame: Approximately 5 weeks
2 secondary outcomes
Pain scores, assessed by VAS for ongoing and evoked pain, recorded after sensitization with topical 1% capsaicin. Pain scores following single oral doses of ABX-1431 will be compared to those following placebo and no treatment.
Time frame: Approximately 5 weeks
Severity of, and Number of Participants With Clinical and Laboratory Adverse Events (AE) following single oral doses of ABX-1431, placebo and no treatment as a Measure of Safety and Tolerability.
Time frame: Approximately 5 weeks
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 2 Apr 2018.
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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.
Irene Tracey, DPhil., FRCA principal investigator
University of Oxford
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 ABX-1431 in people with Pain, run by Abide Therapeutics 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 9 inclusion and 14 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 2 Apr 2018. 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?
Brain activity in response to noxious stimuli, as assessed by fMRI, following a single dose of ABX-1431, compared to the same outcome following placebo and no treatment interventions. (time frame: Approximately 5 weeks). 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 2 Apr 2018.