Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483990
Status:
COMPLETED
Last Update Posted:
2010-07-15
First Post:
2007-06-06
Brief Title:
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
Sponsor:
Plethora Solutions Ltd
Organization:
Plethora Solutions Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 subjects 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 31 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
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 31 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None