Recent Updates
Recently added Catalysts

Iloperidone

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Mar 14, 2013

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01529294Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy VolunteersPHASE1 COMPLETED 90 — — Aug 1, 2010Jul 1, 2012Mar 14, 20134 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Measure: Area Under Curve (AUClast, AUCinf) and maximum concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose

Pharmacokinetics of iloperidone in subjects with mild or moderate hepatic impairment, compared to healthy volunteers.

Maximum plasma concentration following drug administration (Cmax) of iloperidone
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose

Blood and urine samples will be collected and plasma and urine concentration will be measured.

Protein binding of iloperidone
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose

Blood samples will be collected and protein binding will be measured .

Area under the plasma concentration-time Curve from time zero to infinity (AUCinf) of iloperidone
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose

Blood and urine samples will be collected and plasma and urine concentration will be measured.

Secondary Endpoints
Area Under the plasma Curve (AUC) of iloperidone metabolite P88
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose
Area under the plasma concentration-time Curve from time zero to infinity (AUCinf) of iloperidone metabolite P88 records, listed by subject. Summary statistics provided by impairment group and visit/time.
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose
Maximum plasma concentration following drug administration (Cmax) of iloperidone metabolites P88
pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
IloperidoneEXPERIMENTALEligible subjects receive a single oral dose of 2 mg iloperidone as a tablet
Interventions
NameTypeDescription
IloperidoneDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Inclusion criteria (all subjects): * Caucasian subjects * Inclusion criteria (hepatic impaired subjects): * subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance...

Countries:United States
Unlock Eligibility Criteria