Recent Updates
Recently added Catalysts

16448

Phase 2

Premature Ejaculation | Small molecule | Other |GSK plc|Last Updated: Mar 19, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00537459A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature EjaculationPHASE2 COMPLETED 18 — — Dec 1, 2006 -Mar 19, 20121 Ireland
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
-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 Endpoints
Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose
1-2h, post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
16448DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersNo
Study Sites1

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 his...

Countries:Ireland
Unlock Eligibility Criteria