Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation

Study Overview
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Brief Summary
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An open label, placebo and positive controlled, randomised, cross-over study in healthy male volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine product PET500

Detailed Description
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This was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over pilot study. On each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg), or placebo, or Stud100® (which served as a positive control) on the glans penis The doses of PET500 were applied in liquid spray form (260μl) at approximately the same time of the day as the previous application to locations on the glans penis in a randomised fashion. Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP. The first two volunteers included in the trial piloted the sensitivity assessments prior to the inclusion of all other subjects. Changes could be made to the assessment times on the basis of the pilot data to ensure subsequent timings were relevant. However any such changes were not to expose volunteers to more assessments than were specified in the study protocol.

Official Title
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An Open Label, Placebo and Positive Controlled, Randomised, Cross-over Study in Healthy Male Volunteers to Determine the Effect on Penile Skin Sensation of a Newly Formulated Tetracaine Product PET500

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Tetracaine
* Other: Matching placebo (PET500)
* Drug: STUD100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: Male healthy subject aged 18 to 65 years, inclusive. The subject is capable of understanding and complying with protocol requirements. The subject is in good health as determined by medical history and physical examination at screening. The subject signs a written, informed consent form prior to the initiation of any study procedures Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1 History or hypersensitivity to tetracaine or ethanol. 2. History or signs of a sexually transmitted disease. 3. Any current penile abnormalities. 4. Known current drug abuser or alcoholic as determined by medical history. 5. Participation in a clinical trial within the last month prior to dosing on Day 1. 6. The use of concomitant systemic or topical medications or foods that may affect the study outcome and / or impair drug metabolising capacity. 7. A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result. 8. Unfit to participate in the study in the opinion of the Principal Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Sequential Assignment
Interventional Model Description: Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET500 (0.1%)<br>Each actuation of the pump spray dispenses 130µl PET500. Two pumps will dispense 260µl as follows: PET500 (0.1%) corresponding to a tetracaine total dose of 0.26mg | Drug: Tetracaine<br>* Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.<br>* Other names: PET500 tetracaine spray;|
| Experimental: PET500 (0.25%)<br>Each actuation of the pump spray dispenses 130µl PET500. Two pumps will dispense 260µl as follows: PET500 (0.25%) corresponding to a tetracaine total dose of 0.65mg | Drug: Tetracaine<br>* Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.<br>* Other names: PET500 tetracaine spray;|
| Experimental: PET500 (0.5%)<br>Each actuation of the pump spray dispenses 130µl PET500. Two pumps will dispense 260µl as follows: PET500 (0.5%) corresponding to a tetracaine total dose of 1.3mg | Drug: Tetracaine<br>* Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.<br>* Other names: PET500 tetracaine spray;|
| Experimental: PET500 placebo comparator<br>Each actuation of the pump spray dispenses 130µl PET500 [vehicle only]. Two pumps will dispense 260µl | Other: Matching placebo (PET500)<br>* Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.<br>* Other names: PET500 Matching Placebo;|
| Active Comparator: STUD100 (9.6%)<br>Each actuation of the pump spray dispenses 130µl, corresponding to a dose of 7.7mg lidocaine. Three pumps will dispense 390µl of a 9.6% solution, delivering a total dose of 23mg lidocaine. UK License Number PL/2294/5000R | Drug: STUD100<br>* Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.<br>* Other names: STUD100 desensitizing spray for men;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis assessed using Von Frey fibres (monofilaments) to measure touch sensitivity | To determine the onset of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis (compared to placebo and positive prilocaine/lidocaine control). | 2 Months | 
| Duration of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis using Von Frey fibres (monofilaments) to measure touch sensitivity | To determine the duration of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis (compared to placebo and positive prilocaine/lidocaine control). | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events for PET500 | To determine incidence, of adverse events by Treatment group for doses of a newly formulated tetracaine spray PET500 in healthy male volunteers. | 2 months | 
| Intensity and relationship of adverse events to PET500 | To determine intensity and relationship to study drug of adverse events by Treatment group for doses of a newly formulated tetracaine spray PET500 in healthy male volunteers. | 2 months |