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

Futura Medical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: STUD100; Other: Matching placebo (PET500); Drug: Tetracaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04247230

FM48

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

PET500 (0.1%)

Experimental group

Description:

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

Treatment:

Drug: Tetracaine

PET500 (0.25%)

Experimental group

Description:

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

Treatment:

Drug: Tetracaine

PET500 (0.5%)

Experimental group

Description:

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

Treatment:

Drug: Tetracaine

PET500 placebo comparator

Experimental group

Description:

Each actuation of the pump spray dispenses 130µl PET500 \[vehicle only\]. Two pumps will dispense 260µl

Treatment:

Other: Matching placebo (PET500)

STUD100 (9.6%)

Active Comparator group

Description:

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

Treatment:

Drug: STUD100