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

• Status: Completed
• Trial end date: 2009-02-23
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Futura Medical Developments Ltd.
• Collaborator: Richmond Pharmacology Limited
• Treatments: Tetracaine

Criteria

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.