CAPSAICIN CHALLENGE STUDY TO INVESTIGATE THE POTENTIAL ANALGESIC EFFECTS OF V113741 IN HEALTHY MALE SUBJECTS

INTERVENTION: 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 number: 0.75‐ INN or Proposed INN: Morphine CAS Number: 52‐26‐6 Other descriptive name: opiods Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.00‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Trade Name: Morphine Product Name: Morphine Pharmaceutical Form: Injection* CONDITION: Modeling inflammatory and neuropathic pain ; MedDRA version: 12.0 Level: LLT Classification code 10054095 Term: Neuropathic pain PRIMARY OUTCOME: Main Objective: To assess potential effects of V113741 on the area of secondary hyperalgesia after intradermal capsaicin administration using punctuate stimulation 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.; ; 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; 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 s