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
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|ClinicalTrials.gov Identifier: NCT00483990|
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : July 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PSD502||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2007|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483990
|United States, Kansas|
|PRA International - Clinical Pharmacology Center|
|Lenexa, Kansas, United States, 66219|
|Principal Investigator:||Steven F. Komjathy, MD||PRA Health Sciences|