Osteoarthritis, KneePhase 1NCT02337543
NEO6860, a TRPV1 Antagonist, First in Human Study
A Phase 1 study testing NEO6860 in people with Osteoarthritis, Knee, run by Neomed Institute at 1 site in United Kingdom.
Trial summary
This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- NEO6860
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jul 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 and females Any ethnic origin Between 18 and 55 years of age Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive Body weight between 50 kg and 100 kg inclusive Subjects must be in good health, as determined by Medical history, Physical examination, Vital sign assessment, 12-lead electrocardiogram (ECG), Clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is acceptable) Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as a condom with spermicidal foam/gel/film/cream/suppository), or to refrain from donating sperm from the time of the first dose until 3 months after the final dosing occasion.
- Subjects who have donated blood in the 3 months prior to screening, plasma in the 7 days prior to screening or platelets in the 6 weeks prior to screening Subjects who consume more than 28 units of alcohol per week if male or consume more than 21 units of alcohol per week if female
- Subjects who have used any medication within 7 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety:
- Subjects who have a clinically significant pulse rate, blood pressure or temperature that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening and prior to first dose Subjects with a positive urine drug screen (confirmed by repeat) at screening or first admission, or a positive alcohol breath test result (confirmed by repeat) at screening or first admission Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator ALT or AST >1.5 times ULN at screening and/or prior to first dose, confirmed by repeat testing Subjects considered non-acceptable responders to the intradermal capsaicin test at screening, defined as maximum VAS score of <3 or 10 Subjects who, in the opinion of the Investigator, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NEO6860: A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects
This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects.
Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender.
The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods.
Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an ascending multiple dose, with 2 dose levels.
Read the detailed description
This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects.
Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender.
The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods. Measurement of capsaicin evoked pain, and secondary hyperalgesia will be performed at baseline and at estimated Tmax and 8 hours post dosing.
Part A will comprise an ascending single dose, sequential group study in male subjects, incorporating a two-period crossover group to investigate the effect of food and a single group of female subjects to investigate gender effect.
56 subjects will be studied in 7 groups (Groups A1 to A7), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo). Six dose levels will be explored: 50, 100, 200, 400, 800 and 1 600mg.
Part B will comprise an ascending multiple dose, sequential group study. 16 subjects will be studied in 2 groups (Groups B1 to B2), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo) receiving 5 days of therapy with a dose schedule to be determined during Part A.
- Conditions
- Osteoarthritis, Knee
- Being tested
- NEO6860, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEO6860Drug
NEO6860 is an NCE acting as a TRPV1 antagonist
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active: NEO6860 | Experimental | NEO6860 suspension is the drug under evaluation Receives: Drug: NEO6860 |
| placebo | Placebo comparator | Placebo matching NEO6860 suspension formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of NEO6860 in healthy subjects
Measured: 10 days
Secondary outcomes (4)
Pharmacokinetics of NEO6860 in healthy subjects
Measured: 10 days
Food effect on Pharmacokinetics of NEO6860 in healthy subjects
Measured: 10 days
Gender effect on Pharmacokinetics of NEO6860 in healthy subjects
Measured: 10 days
Pharmacodynamics effect (ID Capsaicin test) of NEO6860 in healthy subjects
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neomed Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Dan A Chiche, MD, Study director, Neomed Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337543
- Sponsor's protocol ID
- NEO6860-1301
- Status last verified
- Oct 2015
- First submitted
- 9 Jan 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown W, Leff RL, Griffin A, Hossack S, Aubray R, Walker P, Chiche DA. Safety, Pharmacokinetics, and Pharmacodynamics Study in Healthy Subjects of Oral NEO6860, a Modality Selective Transient Receptor Potential Vanilloid Subtype 1 Antagonist. J Pain. 2017 Jun;18(6):726-738. doi: 10.1016/j.jpain.2017.01.009. Epub 2017 Feb 8.
PubMed 28188907
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEO6860: A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02337543
- Acronym / sponsor ID
- NEO6860-1301
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Neomed InstituteUniversity, hospital or other
- Collaborators
- Covance
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 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.
This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects.
Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender.
The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods.
Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an ascending multiple dose, with 2 dose levels.
Detailed description
This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects.
Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender.
The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods. Measurement of capsaicin evoked pain, and secondary hyperalgesia will be performed at baseline and at estimated Tmax and 8 hours post dosing.
Part A will comprise an ascending single dose, sequential group study in male subjects, incorporating a two-period crossover group to investigate the effect of food and a single group of female subjects to investigate gender effect.
56 subjects will be studied in 7 groups (Groups A1 to A7), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo). Six dose levels will be explored: 50, 100, 200, 400, 800 and 1 600mg.
Part B will comprise an ascending multiple dose, sequential group study. 16 subjects will be studied in 2 groups (Groups B1 to B2), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo) receiving 5 days of therapy with a dose schedule to be determined during Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: NEO6860 | Experimental | Drug: NEO6860NEO6860 suspension is the drug under evaluation |
| placebo | Placebo comparator | Drug: PlaceboPlacebo matching NEO6860 suspension formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females Any ethnic origin Between 18 and 55 years of age Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive Body weight between 50 kg and 100 kg inclusive Subjects must be in good health, as determined by Medical history, Physical examination, Vital sign assessment, 12-lead electrocardiogram (ECG), Clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is acceptable) Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (4 listed)
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as a condom with spermicidal foam/gel/film/cream/suppository), or to refrain from donating sperm from the time of the first dose until 3 months after the final dosing occasion.
- Subjects who have donated blood in the 3 months prior to screening, plasma in the 7 days prior to screening or platelets in the 6 weeks prior to screening Subjects who consume more than 28 units of alcohol per week if male or consume more than 21 units of alcohol per week if female
- Subjects who have used any medication within 7 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety:
- Subjects who have a clinically significant pulse rate, blood pressure or temperature that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening and prior to first dose Subjects with a positive urine drug screen (confirmed by repeat) at screening or first admission, or a positive alcohol breath test result (confirmed by repeat) at screening or first admission Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator ALT or AST >1.5 times ULN at screening and/or prior to first dose, confirmed by repeat testing Subjects considered non-acceptable responders to the intradermal capsaicin test at screening, defined as maximum VAS score of <3 or 10 Subjects who, in the opinion of the Investigator, should not participate in the study
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 |
|---|---|---|
| NEO6860NEO6860 is an NCE acting as a TRPV1 antagonist | Drug | Active: NEO6860 |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Safety and tolerability of NEO6860 in healthy subjects
Time frame: 10 days
4 secondary outcomes
Pharmacokinetics of NEO6860 in healthy subjects
Time frame: 10 days
Food effect on Pharmacokinetics of NEO6860 in healthy subjects
Time frame: 10 days
Gender effect on Pharmacokinetics of NEO6860 in healthy subjects
Time frame: 10 days
Pharmacodynamics effect (ID Capsaicin test) of NEO6860 in healthy subjects
Time frame: 10 days
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 10 Mar 2016.
- Derived from this study: PubMed 28188907Brown W, Leff RL, Griffin A, Hossack S, Aubray R, Walker P, Chiche DA. Safety, Pharmacokinetics, and Pharmacodynamics Study in Healthy Subjects of Oral NEO6860, a Modality Selective Transient Receptor Potential Vanilloid Subtype 1 Antagonist. J Pain. 2017 Jun;18(6):726-738. doi: 10.1016/j.jpain.2017.01.009. Epub 2017 Feb 8.
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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.
Dan A Chiche, MD study director
Neomed Institute
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 NEO6860 in people with Osteoarthritis, Knee, run by Neomed Institute 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 1 inclusion and 4 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 10 Mar 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?
Safety and tolerability of NEO6860 in healthy subjects (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337543, which also lists 1 linked publication.
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 10 Mar 2016.