HealthyPhase 1NCT00483990
Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers
A Phase 1 study testing PSD502 in people with Healthy, run by Plethora Solutions Ltd at 1 site in United States.
Trial summary
The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PSD502
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2007
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Male, aged 18 years and over
- In generally good health in the opinion of the Investigator
- Willing and able to comply with all study procedures in the opinion of the Investigator
Who cannot join
- History of a significant medical condition that would preclude further study participation, in the opinion of the Investigator.
- Currently taking, or has taken within the 2 weeks prior to the Screening Visit, any concomitant medication that could confound interpretation of the safety data PSD502
- Suffering from an STD, or is positive for hepatitis B, hepatitis C, or HIV infection.
- Safety testing abnormalities at the Screening Visit, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation, in the opinion of the Investigator.
- Significant abnormality of the glans penis that would preclude interpretation of the examination of the glans, or that could be worsened by use of PSD502.
- History of alcohol or drug abuse within 1 year prior to the Screening visit.
Show all 11Show fewer
- Known drug sensitivity to amide-type local anesthetics.
- Use of an investigational (non-registered drug within 30 days of the Screening Visit.
- Unlikely to understand or be able to comply with study procedures, for any reason, in the opinion of the Investigator.
- History of Glucose-6-Phosphate Dehydrogenase (G-6-PD)deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).
- Use of class 1 (e.g. mexiletine, tocainide) and III (e.g. amiodarone, sotaolol)anti-arrhythmic drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA International - Clinical Pharmacology Center
Lenexa, Kansas, 66219
About this study
Official title: A Phase I, Double-blind, Stratified, Parallel Group, Placeob-controlled Study of the Safety, Tolerability and Pharmacokinetics of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times Daily for 21 Days in Healthy Male Volunteers
The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers
Read the detailed description
This is a phase I, double-blind, stratified, parallel group, placebo-controlled repeat dose study in a minimum of 8 circumcised and 8 uncircumcised healthy male volunteers. Subjects will attend 2 study visits, of which 1 will be a Screening Visit (Visit 1) and the other, a consecutive 21-day treatment visit (Visit 2; Days 1-21) which commences no more than 14 days after the Screening visit. Subjects will reside in the phase I unit throughout the treatment period. The duration of each subject's participation in the study will be up to 5 weeks.
Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 3:1 ratio.
Procedures during the 21 day treatment period include: visual examination of the glans penis, blood sample collection for pharmacokinetic analysis of lidocaine and prilocaine, swabbing of the glans penis for residual PSD502, vital signs and 12-lead ECG, adverse event enquiries and collection of concomitant medications. Subjects are discharged from the clinic on Day 21 following a safety evaluation.
- Conditions
- Healthy
- Being tested
- PSD502
- Keywords
- Phase I Study in healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSD502Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on: -Examination of glans penis -AEs & SAEs -Reasons for withdrawals -Use of concomitant medications -Vital signs & ECG -Urinalysis, hematology & biochemistry -Residual PSD502 on swabs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- Plethora Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven F. Komjathy, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483990
- Sponsor's protocol ID
- PSD502-PE-003
- Status last verified
- Jul 2010
- First submitted
- 6 Jun 2007
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Stratified, Parallel Group, Placeob-controlled Study of the Safety, Tolerability and Pharmacokinetics of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times Daily for 21 Days in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00483990
- Acronym / sponsor ID
- PSD502-PE-003
- Conditions
- Healthy
- Keywords
- Phase I Study in healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- Plethora Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Jun 2007 (estimated)
- 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.
The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers
Detailed description
This is a phase I, double-blind, stratified, parallel group, placebo-controlled repeat dose study in a minimum of 8 circumcised and 8 uncircumcised healthy male volunteers. Subjects will attend 2 study visits, of which 1 will be a Screening Visit (Visit 1) and the other, a consecutive 21-day treatment visit (Visit 2; Days 1-21) which commences no more than 14 days after the Screening visit. Subjects will reside in the phase I unit throughout the treatment period. The duration of each subject's participation in the study will be up to 5 weeks.
Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 3:1 ratio.
Procedures during the 21 day treatment period include: visual examination of the glans penis, blood sample collection for pharmacokinetic analysis of lidocaine and prilocaine, swabbing of the glans penis for residual PSD502, vital signs and 12-lead ECG, adverse event enquiries and collection of concomitant medications. Subjects are discharged from the clinic on Day 21 following a safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent
- Male, aged 18 years and over
- In generally good health in the opinion of the Investigator
- Willing and able to comply with all study procedures in the opinion of the Investigator
Key exclusion criteria (11 listed)
- History of a significant medical condition that would preclude further study participation, in the opinion of the Investigator.
- Currently taking, or has taken within the 2 weeks prior to the Screening Visit, any concomitant medication that could confound interpretation of the safety data PSD502
- Suffering from an STD, or is positive for hepatitis B, hepatitis C, or HIV infection.
- Safety testing abnormalities at the Screening Visit, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation, in the opinion of the Investigator.
- Significant abnormality of the glans penis that would preclude interpretation of the examination of the glans, or that could be worsened by use of PSD502.
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 |
|---|---|---|
| PSD502 | Drug | – |
Primary outcome
Safety based on: -Examination of glans penis -AEs & SAEs -Reasons for withdrawals -Use of concomitant medications -Vital signs & ECG -Urinalysis, hematology & biochemistry -Residual PSD502 on swabs
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 15 Jul 2010.
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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.
Steven F. Komjathy, MD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PSD502 in people with Healthy, run by Plethora Solutions Ltd at 1 site in United States.
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 4 inclusion and 11 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 15 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Safety based on: -Examination of glans penis -AEs & SAEs -Reasons for withdrawals -Use of concomitant medications -Vital signs & ECG -Urinalysis, hematology & biochemistry -Residual PSD502 on swabs. 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 15 Jul 2010.