Healthy VolunteersPhase 1FM48NCT04247230
Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation
A Phase 1 study testing Tetracaine and STUD100 in people with Healthy Volunteers, run by Futura Medical Developments Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tetracaine and STUD100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2008to 23 Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- 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
Who cannot join
- 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.
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- 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.
About this study
Official 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
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
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Tetracaine, Matching placebo (PET500), STUD100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracaineDrug
Also called PET500 tetracaine spray
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Matching placebo (PET500)Other
Also called PET500 Matching Placebo
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
STUD100Drug
Also called STUD100 desensitizing spray for men
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Tetracaine |
| PET500 placebo comparator | Experimental | Each actuation of the pump spray dispenses 130µl PET500 [vehicle only]. Two pumps will dispense 260µl Receives: 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 Receives: Drug: STUD100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 Months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start3 Sep 2008
- Primary completion20 Oct 2008
- Study completion23 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Futura Medical Developments Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, Dr, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247230
- Sponsor's protocol ID
- FM48
- Acronym
- FM48
- Status last verified
- Jan 2020
- First submitted
- 14 Dec 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04247230
- Acronym / sponsor ID
- FM48 / FM48
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Futura Medical Developments Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- 3 Sep 2008 (actual)
- Primary completion
- 20 Oct 2008 (actual)
- Study completion
- 23 Feb 2009 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
| Arm | Type | Receives |
|---|---|---|
| PET500 (0.1%) | Experimental | Drug: TetracaineEach 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 |
| PET500 (0.25%) | Experimental | Drug: TetracaineEach 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 |
| PET500 (0.5%) | Experimental | Drug: TetracaineEach 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 |
| PET500 placebo comparator | Experimental | Other: Matching placebo (PET500)Each actuation of the pump spray dispenses 130µl PET500 [vehicle only]. Two pumps will dispense 260µl |
| STUD100 (9.6%) | Active comparator | Drug: STUD100Each 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetracaineAlso: PET500 tetracaine sprayVon Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP. | Drug | PET500 (0.1%), PET500 (0.25%), PET500 (0.5%) |
| Matching placebo (PET500)Also: PET500 Matching PlaceboVon Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP. | Other | PET500 placebo comparator |
| STUD100Also: STUD100 desensitizing spray for menVon Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP. | Drug | STUD100 (9.6%) |
Primary outcome
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
Time frame: 2 Months
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).
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
Time frame: 2 Months
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 secondary outcomes
Incidence of adverse events for PET500
Time frame: 2 months
Intensity and relationship of adverse events to PET500
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorg Taubel, Dr principal investigator
Richmond Pharmacology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetracaine and STUD100 in people with Healthy Volunteers, run by Futura Medical Developments Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.