Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation (FM48)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Tetracaine; Other: Matching placebo (PET500); Drug: STUD100

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Male healthy subject aged 18 to 65 years, inclusive.
2. The subject is capable of understanding and complying with protocol requirements.
3. The subject is in good health as determined by medical history and physical examination at screening.
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET500 (0.1%); 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; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Other Names: PET500 tetracaine spray
Experimental: PET500 (0.25%); 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; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Other Names: PET500 tetracaine spray
Experimental: PET500 (0.5%); 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; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Other Names: PET500 tetracaine spray
Experimental: PET500 placebo comparator; Each actuation of the pump spray dispenses 130µl PET500 [vehicle only]. Two pumps will dispense 260µl	Other: Matching placebo (PET500); Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Other Names: PET500 Matching Placebo
Active Comparator: STUD100 (9.6%); 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; Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.; Other Names: STUD100 desensitizing spray for men

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Futura Medical Developments Ltd.
• Collaborators: Richmond Pharmacology Limited
• Investigators: Principal Investigator: Jorg Taubel, Dr, Richmond Pharmacology

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2008
• Primary Completion (Actual): October 20, 2008
• Study Completion (Actual): February 23, 2009

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Tetracaine
• Other Study ID Numbers: FM48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No