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

NCT00483990 | Completed Phase 1

• 1 other identifier: PSD502-PE-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Phase I Study in healthy subjects

Outcome Measures

Primary Outcomes (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

Interventions

PSD502 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Plethora Solutions Ltd: lead

Study Sites (1)

PRA International - Clinical Pharmacology Center

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Steven F. Komjathy, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

US (1)