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VHX-896

Phase 1

Healthy | Small molecule | Other |Vanda Pharmaceuticals Inc.|Last Updated: Jan 31, 2025

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
RandomizedCONTROLLED
Total Trials2
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06803290Food Effect Study of VHX-896 in Healthy VolunteersPHASE1 COMPLETED 24Jun 21, 2022Dec 27, 2022Jan 31, 20251 United States
NCT04969211Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy VolunteersPHASE1 COMPLETED 25Jun 30, 2021Oct 13, 2021Jul 11, 20221 United States
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Study Endpoints
Primary Endpoints
Comparative bioavailability of VHX-tablets under fed versus fasted conditions.
96 Hours

As measured by plasma concentrations

Bioequivalence between VHX-896 tablets relative to iloperidone tablets
96 hours

as measured by plasma concentrations

Assessment of Safety and Tolerability of a single dose of VHX-896
17 days

As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs

Secondary Endpoints
Assessment of safety and tolerability of single dose of VHX-896 tablets
17 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence A: fed then fastedEXPERIMENTAL -
Sequence B: fasted then fedEXPERIMENTAL -
Sequence A: VHX-896 then iloperidoneEXPERIMENTAL -
Sequence B: Iloperidone then VHX-896EXPERIMENTAL -
Interventions
NameTypeDescription
VHX-896DRUGOral tablet
VHX-896 and iloperidoneDRUGoral tablet
Iloperidone and VHX-896DRUGoral tablet
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female participants between 18 to 55 years (inclusive). * Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2). * Good health as determined by no clinically significant deviations from normal in medical history, cl...

Countries:United States
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