A Phase 1 interventional study of Iloperidone in Hepatic Impairment, sponsored by Novartis Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-14.
Sponsored by Novartis Pharmaceuticals · Phase 1 and Interventional
This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 90 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Eligible subjects receive a single oral dose of 2 mg iloperidone as a tablet
Drug: Iloperidone
Measure: Area Under Curve (AUClast, AUCinf) and maximum concentration (Cmax)
Pharmacokinetics of iloperidone in subjects with mild or moderate hepatic impairment, compared to healthy volunteers.
Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Maximum plasma concentration following drug administration (Cmax) of iloperidone
Blood and urine samples will be collected and plasma and urine concentration will be measured.
Time frame: 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
Protein binding of iloperidone
Blood samples will be collected and protein binding will be measured .
Time frame: 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
Blood and urine samples will be collected and plasma and urine concentration will be measured.
Time frame: 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 Curve (AUC) of iloperidone metabolite P88
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured
Time frame: 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.
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured
Time frame: 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
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured
Time frame: 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
Protein binding of iloperidone metabolites P88 (CLr)
Blood samples will be collected and protein binding of metabolite 88 will be measured
Time frame: 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 Curve (AUC) of iloperidone metabolite P95
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured
Time frame: 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 P95
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured
Time frame: 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 P95
Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured
Time frame: 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
Protein binding of iloperidone metabolites P95
Blood samples will be collected and protein binding of metabolite 95 will be measured
Time frame: 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
Number of participants with adverse events
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on Electrocardiograms (ECGs)
Time frame: Day 6
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals