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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

This study has been completed.
Sponsor:
Information provided by:
Plethora Solutions Ltd
ClinicalTrials.gov Identifier:
NCT00483990
First received: June 6, 2007
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: PSD502
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Plethora Solutions Ltd:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 16
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483990

Locations
United States, Kansas
PRA International - Clinical Pharmacology Center
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Plethora Solutions Ltd
Investigators
Principal Investigator: Steven F. Komjathy, MD PRA International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00483990     History of Changes
Other Study ID Numbers: PSD502-PE-003
Study First Received: June 6, 2007
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prilocaine
Lidocaine
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on May 16, 2013