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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP2015_dose 1 | Experimental | Active |
|
| IP2015_dose 2 | Experimental | Active |
|
| Placebo | Placebo Comparator | Placebo |
|
| Pregabalin | Active Comparator | Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IP2015, dose 1 | Drug | Active |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain related assessments of effect | The area of hyperalgesia | A 6 hours time interval after dosing |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Thomsen | Contact | 23276134 | mt@initiatorpharma.com | |
| Claus Olesen | Contact | 61260035 | ceo@initiatorpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Connell, MD | MAC UK | Principal Investigator |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D005680 | gamma-Aminobutyric Acid |
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| IP2015, dose 2 |
| Drug |
Active |
|
|
| Placebo | Drug | Placebo |
|
| Pregabalin | Drug | Comparator |
|
|
| 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 |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |