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Iloperidone

Phase 1

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

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Iloperidone · 1 trial · 1 indication

Phase 1 1
NCT01529294Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy VolunteersHepatic Impairment
COMPLETED90 Analytics
PHASE1COMPLETED
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
Hepatic ImpairmentUnlock trial analytics

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
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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 -
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Iloperidone

What is Iloperidone used for in Hepatic Impairment?

Iloperidone is a small molecule being studied for use in patients with hepatic impairment, specifically to evaluate its pharmacokinetics in mild or moderate liver disease. It is currently in Phase 1 clinical development as an investigational drug, and it is not approved for this condition.

Who makes Iloperidone?

Iloperidone is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting clinical research to assess the drug's behavior in patients with hepatic impairment.

What phase is Iloperidone in?

Iloperidone is in Phase 1 clinical development for hepatic impairment. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use and is still undergoing clinical trials to evaluate its safety and pharmacokinetics.

What clinical trials is Iloperidone in?

Iloperidone has one completed clinical trial, NCT01529294, titled 'Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers.' This Phase 1 study enrolled 90 participants in the United States and included healthy volunteers.

Is Iloperidone the same as any other drug?

Iloperidone is also known by other names, though specific alternative names are not provided in the available information. It is a distinct small molecule being investigated for hepatic impairment.