Modeling inflammatory and neuropathic pain MedDRA version: 12.0 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Interventions
Product Name: V113741
Product Code: V113741
Pharmaceutical Form: Oral solution
Current Sponsor code: V113741
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
Purdue Pharma L.P.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender: male 2. Age: between 18 and 55 years of age, inclusive 3. Body mass index (BMI): 18 - 29 kg/m2, inclusive 4. Response to intradermal capsaicin injection with an area of secondary hyperalgesia by punctuate stimulation =30 cm2 5. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice), nicotine and tobacco products from 48 h prior to and until discharge from the clinic for each study period 6. Medical history without major pathology 7. Willingness to sign the written Informed Consent Form (ICF) 8. Willingness to use adequate contraception from the time of dosing until 3 months after the follow-up visit 9. Willingness to abstain from sunbathing from 48 hours before admission to the clinic and treatment period for each study period 10. Willingness to abstain from using any skin cream in the test areas of the arms during each study period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of clinically relevant pathology 2. Scar tissue on the anterior side of the forearm(s) 3. Presence of copious hair on the anterior side of the forearms 4. Mental handicap 5. History of frequent nausea or emesis regardless of etiology 6. History of seizures or head trauma with sequelae 7. Significant illness during the 30 days preceding entry into this study 8. Abnormalities on physical examination, vital signs, ECG or clinical laboratory values unless those abnormalities were judged clinically insignificant by the Investigator 9. Any cardiovascular disorders, including hypertension 10. History of serious allergies or allergic to morphine (or other opioids) or capsaicin 11. Abnormal renal function (serum creatinine ? 110 ?mol/L or serum urea ? 8.0 mmol/L) 12. Regular/routine treatment with non-topical medications within 30 days prior to drug administration 13. Recent (within the last year) alcohol abuse or drug addiction. Use of cannabis must have been stopped at least 14 days prior to the first dose. 14. Use of concomitant medication, except for acetaminophen, which is allowed up to 3 days prior to first dose, and multivitamins and vitamin C, which are allowed up to 7 days prior to the first dose. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to the first dose. 15. Individuals with electrolyte imbalance. 16. Positive results of urine drug screen (blood, urine or breath), HBsAg, HBsAb (unless immunized), anti-HCV or anti-HIV 1/2. 17. Presence of Gilbert’s syndrome or any hepatobiliary abnormalities. 18. Individuals with evidence of impaired liver function upon entry into the study evidenced by values > 2 times the upper limit of normal for aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) or bilirubin > 1.3 mg/dL, or in the Investigator’s opinion having liver function impairment to the extent that the subject should not participate in this study. 19. Individuals with a screening or baseline ECG showing a QTcB > 450 msec, a PR interval > 240 msec or 40 msec or depth > 0.5 mV), resting heart rate less than 45 or greater than 100 bpm, complete left bundle branch block, right bundle branch block or incomplete right bundle branch block. 20. Individuals with an oxygen saturation (SpO2) < 94% as measured by pulse oximetry. 21. Individuals who have donated blood or blood products within 30 days prior to study drug administration or anytime during the study, except as required by this protocol. 22. Individuals who have used any investigational medication within 30 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess potential effects of V113741 on the area of secondary hyperalgesia after intradermal capsaicin administration using punctuate stimulation;Secondary Objective: To assess potential effects of V113741 on the area of allodynia after intradermal capsaicin administration using a standardized brush To assess the effect of the positive comparator morphine on the pain measure described To determine potential CNS effects of V113741 by pupillometry To assess the safety, tolerability and pharmacokinetics (PK) of V113741 ;Primary end point(s): Pharmacodynamics: The area of secondary hyperalgesia using Von Frey monofilament and allodynia using a brush will be measured. VAS will be assessed after capsaicin administration. Pharmacokinetics: V113741 concentrations in plasma will be determined; pharmacokinetic parameters of V113741 will be calculated. Safety: Safety will be monitored by assessing AEs, vital signs, SpO2, telemetry, pupillometry. | — |
Countries
Netherlands
Outcome results
None listed