Clinical Trial: A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Two-session Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an 16448 in Healthy Males With

Brief Summary:

16448 is being investigated for the treatment of primary premature ejaculation (PE) using a novel mode of action. There are no approved therapies for premature ejaculation, and novel therapies are needed for this syndrome.

16448 has been shown to increase ejaculatory latency in the PCA rat model of premature ejaculation.

A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory latency time in this study. This device, which measures ELT under standard conditions, has been shown to provide a more reliable measure of ejaculatory latency compared to the use of a stopwatch during sexual intercourse

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: -vital signs, ECGs, clinical laboratory tests, adverse events at 24h -area under plasma drug concentration versus time curve [AUC (0-t),AUC (0-8)], maximum observed plasma concentration (Cmax),time at max concentration(Tmax)& half life (T1/2) [ Time Frame: 24h ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose [ Time Frame: 1-2h, post-dose ]

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: January 25, 2007
Date Started: December 2006
Date Completion:
Last Updated: March 15, 2012
Last Verified: February 2011