Proof of Mechanism in ELT

Study Overview
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Brief Summary
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The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE

Official Title
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A Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of a Single Oral Dose of GSK958108 on Ejaculatory Latency Time (ELT) in Male Patient Suffering From Premature Ejaculation

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: GSK958108
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation Baseline Ejaculation Latency time < 3 minutes Subjects must agree to use a contraception methods as per protocol Body weight > or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2 Subject with normal visual acuity (with appropriate correction if needed) Subject able to cooperate in all study procedure including the eye examination with use of mydriatics Exclusion Criteria: Erectile dysfunction History of migraine Current clinically relevant abnormality History of psychiatric illness or suicidal attempts or behaviours History of any eye disorder or colour blind, excluding myopia and presbyopia Cardiac conduction disorder or other clinically significant cardiac disease Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests Regular consumption of alcohol History of sensitivity or intolerance to drugs Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids] from 7 days prior to the first dose of study medication Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication Participation in another clinical trial in the previous month Exposure to more than four new experimental drugs within the previous 12 months Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. Unwillingness or inability to follow the procedures outlined in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK958108 3 mg<br>Experimental | Drug: GSK958108<br>* Coated Tablets 1 mg<br>|
| Placebo Comparator: Placebo of GSK958108<br>Placebo | Drug: Placebo<br>* Coated tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli |  | 50 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination |  | 8 weeks | 
| Blood concentration of GSK958108 at different timepoints |  | From predose to 30 hours post-dose |