Healthy Volunteers Clinical Trial
— FM48Official title:
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
Verified date | January 2020 |
Source | Futura Medical Developments Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | February 23, 2009 |
Est. primary completion date | October 20, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Futura Medical Developments Ltd. | Richmond Pharmacology Limited |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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