A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Study Overview
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Brief Summary
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The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain. The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.

Official Title
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A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: CT327 (or placebo) followed by placebo (or CT327)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended Exclusion Criteria: Participation in other clinical studies within 3 months before screening Scheduled for surgery, medical treatment or any hospital admission that would fall within the study Use of strong painkillers Use of any analgesic within 24 hours before start of study Use of a regular course of prescribed medication and/or herbal medicine The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas A past history of contact dermatitis, psoriasis or keloid Any clinically significant ECG abnormality at screening A history of drug or other allergy that contraindicates his participation. Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits). Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening. A known history of drug or alcohol abuse. As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study. Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing. Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT327 treatment period 1<br>Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2 | Drug: CT327 (or placebo) followed by placebo (or CT327)<br>* During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.<br>|
| Experimental: CT327 treatment period 2<br>Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2 | Drug: CT327 (or placebo) followed by placebo (or CT327)<br>* During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An alteration in the peripheral sensitisation after treatment with CT327 |  | 2 treatment/testing periods each lasting 4 days and separated by at least 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush. |  | 2 treatment/testing periods each lasting 4 days and separated by at least 10 days |