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
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||March 2007|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Kansas|
|PRA International - Clinical Pharmacology Center|
|Lenexa, Kansas, United States, 66219|
|Principal Investigator:||Steven F. Komjathy, MD||PRA International|