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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Plethora Solutions Ltd
• Treatments: EMLA; Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine

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.