- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929264
An fMRI Study in Healthy Volunteers to Investigate the Effects of ABX-1431 on Experimental Hyperalgesia and Its Neural Correlates
March 30, 2018 updated by: Abide Therapeutics
An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental hyperalgesia and its neural correlates.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Oxford, United Kingdom, OX3 9DU
- University of Oxford
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No Intervention
|
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Experimental: ABX-1431
ABX-1431, capsules, 40 mg, single dose
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Capsules, 40 mg, single dose
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Placebo Comparator: Placebo
Placebo, capsules, single dose
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Capsules, single dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Approximately 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Approximately 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Irene Tracey, DPhil., FRCA, University of Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 11, 2016
Study Record Updates
Last Update Posted (Actual)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 30, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABX-1431_PN003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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