Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model

Study Overview
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Brief Summary
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This is a Phase I, randomised, double-blind, placebo-controlled, 4-way crossover study to investigate the PD effects, safety, tolerability and PK/PD correlation of two single oral dose levels of IP2015 compared to 300 mg pregabalin and placebo in healthy male subjects using the ID capsaicin model.

Official Title
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A Randomised, Double Blind, Placebo Controlled Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model

Conditions
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Pain

Intervention / Treatment
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* Drug: IP2015, dose 1
* Drug: IP2015, dose 2
* Drug: Placebo
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male, with a skin type compatible with capsaicin measurements. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations. Subject must be in good general health with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study. Exclusion Criteria: Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol. Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder). Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP2015_dose 1<br>Active | Drug: IP2015, dose 1<br>* Active<br>* Other names: Test drug;|
| Experimental: IP2015_dose 2<br>Active | Drug: IP2015, dose 2<br>* Active<br>* Other names: Test drug;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Pregabalin<br>Comparator | Drug: Pregabalin<br>* Comparator<br>* Other names: Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related assessments of effect | The area of hyperalgesia | A 6 hours time interval after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related assessments of effect | Subjective rating of pain | A 6 hours time interval after dosing | 
| Pain related assessments of effect | Pain VAS score of hyperalgesia | A 6 hours time interval after dosing | 
| Pain related assessments of effect | Area and pain VAS score of brush-evoked allodynia | A 6 hours time interval after dosing | 
| Pain related assessments of effect | Area of flare (AF) | A 6 hours time interval after dosing |