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Udenafil

Phase 1

Erectile Dysfunction | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Oct 22, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01967264Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican AdultsPHASE1 COMPLETED 83 — — Jul 1, 2013Aug 1, 2013Oct 22, 20131 Mexico
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Study Endpoints
Primary Endpoints
Participants with Adverse Events
3 Weeks

AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).

Secondary Endpoints
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification
Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity
Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
Cmax: Maximum Observed Plasma Concentration
Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Udenafil 150 mg + Udenafil 150 mgEXPERIMENTALUdenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Udenafil 150 mg + PlaceboEXPERIMENTALUdenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Placebo + Udenafil 150 mgEXPERIMENTALPlacebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Placebo + PlaceboPLACEBO_COMPARATORPlacebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Interventions
NameTypeDescription
UdenafilDRUGUdenafil tablets
PlaceboDRUGPlacebo tablets
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Sign a letter of informed consent prior to performing any procedure. 2. Male 3. Clinically healthy 4. Age between 18 and 55 years old. 5. Body Mass Index (BMI) between 18.5 and 24.9. 6. Capability and disposition to attend clinical intervention period Exclusion Criteria: 1....

Countries:Mexico
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