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

NCT04247230 | Completed Phase 1

• 1 other identifier: FM48
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of adverse events for PET500

  2 months

• Intensity and relationship of adverse events to PET500

  2 months

Study Arms (5)

PET500 (0.1%)

EXPERIMENTAL

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

PET500 (0.25%)

EXPERIMENTAL

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

PET500 (0.5%)

EXPERIMENTAL

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

PET500 placebo comparator

EXPERIMENTAL

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

Other: Matching placebo (PET500)

STUD100 (9.6%)

ACTIVE COMPARATOR

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

Interventions

Tetracaine DRUG

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Also known as: PET500 tetracaine spray

PET500 (0.1%); PET500 (0.25%); PET500 (0.5%)

Matching placebo (PET500) OTHER

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Also known as: PET500 Matching Placebo

PET500 placebo comparator

STUD100 DRUG

Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Also known as: STUD100 desensitizing spray for men

STUD100 (9.6%)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History or hypersensitivity to tetracaine or ethanol.
• \. History or signs of a sexually transmitted disease.
• \. Any current penile abnormalities.
• \. Known current drug abuser or alcoholic as determined by medical history.
• \. Participation in a clinical trial within the last month prior to dosing on Day 1.
• \. The use of concomitant systemic or topical medications or foods that may affect the study outcome and / or impair drug metabolising capacity.
• \. A positive HIV 1 \& 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.
• \. Unfit to participate in the study in the opinion of the Principal Investigator.

Sponsors & Collaborators

• Futura Medical Developments Ltd.: lead
• Richmond Pharmacology Limited: collaborator

MeSH Terms

Interventions

Tetracaine; Menogaril

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jorg Taubel, Dr

  Richmond Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: January 30, 2020
• Study Start: September 3, 2008
• Primary Completion: October 20, 2008
• Study Completion: February 23, 2009
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share