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

Study Overview
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Brief Summary
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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

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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: 16448


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Body weight >50kg Body Mass Index (BMI): 19-30 Healthy men with long term (at least 6 months) symptoms of PE Erectile Dysfunction - (patients should have EF(Erectile Function) domain of IIEF(International Index of Erectile Function questionnaire >26 or normal) No history of reduced sexual desire No history of significant psychiatric illness or currently active significant medical illness No SSRI's(Selective Serotonin Reuptake Inhibitors) use within the last 4 months No history of diabetes, renal or hepatic disease No significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis. Exclusion criteria: Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders Subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers Subject has received or is continuing to receive any treatment for PE (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start Subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 16448|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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) |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose |  | 1-2h, post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature ejaculation (PE) ejaculatory latency time (ELT)