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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
Information provided by:
Plethora Solutions Ltd

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

Condition or disease Intervention/treatment Phase
Healthy Drug: PSD502 Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2007
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

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
Sponsors and Collaborators
Plethora Solutions Ltd
Principal Investigator: Steven F. Komjathy, MD PRA Health Sciences

ClinicalTrials.gov Identifier: NCT00483990     History of Changes
Other Study ID Numbers: PSD502-PE-003
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by Plethora Solutions Ltd:
Phase I Study in healthy subjects

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined