Hepatic ImpairmentPhase 1NCT01529294
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
A Phase 1 study testing Iloperidone in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Iloperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2010to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian subjects
- subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance > 50 mL/min (based on Cockroft and Gault formula).
- good general health
- matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.
Who cannot join
- Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .
- History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening
- History of first-dose response/syncope to alpha1-blocking agents
- Patients with symptoms or 6 months past history of encephalopathy.
- Patients with clinical evidence of moderate-severe ascites.
- Patients having a previous surgical porto-systemic shunt.
Show all 9Show fewer
- History of alcohol abuse prior to dosing, or evidence of such abuse during screening.
- Pulse Rate > 200 msec
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Miami, Florida, 33169
Novartis Investigative Site
Orlando, Florida, 32809
Novartis Investigative Site
South Miami, Florida, 33143
About this study
Official title: Open-label, Single-dose, Parallel-group Study to Compare the PKs of Iloperidone in Subjects With Mild or Moderate Hepatic Impairment With That in Matched Healthy Control Subjects
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
- Conditions
- Hepatic Impairment
- Being tested
- Iloperidone
- Keywords
- Hepatic impairment, Iloperidone, ILO522D, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloperidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Iloperidone | Experimental | Eligible subjects receive a single oral dose of 2 mg iloperidone as a tablet Receives: Drug: Iloperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529294
- Sponsor's protocol ID
- CILO522D2401
- Status last verified
- Mar 2013
- First submitted
- 23 Sep 2011
- Last updated
- 14 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-dose, Parallel-group Study to Compare the PKs of Iloperidone in Subjects With Mild or Moderate Hepatic Impairment With That in Matched Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01529294
- Acronym / sponsor ID
- CILO522D2401
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, Iloperidone, ILO522D, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iloperidone | Experimental | Drug: IloperidoneEligible subjects receive a single oral dose of 2 mg iloperidone as a tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian subjects
- subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance > 50 mL/min (based on Cockroft and Gault formula).
- good general health
- matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.
Key exclusion criteria (9 listed)
- Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .
- History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening
- History of first-dose response/syncope to alpha1-blocking agents
- Patients with symptoms or 6 months past history of encephalopathy.
- Patients with clinical evidence of moderate-severe ascites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloperidone | Drug | Iloperidone |
Primary outcome
Measure: Area Under Curve (AUClast, AUCinf) and maximum concentration (Cmax)
Time frame: 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
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
Blood and urine samples will be collected and plasma and urine concentration will be measured.
Protein binding of iloperidone
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
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
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
Blood and urine samples will be collected and plasma and urine concentration will be measured.
9 secondary outcomes
Area Under the plasma Curve (AUC) of iloperidone metabolite P88
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.
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
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)
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
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
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
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
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
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
Related trials for Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement
Not yet recruitingPhase 1
Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function
Obesity, Overweight, T2DM (Type 2 Diabetes Mellitus)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iloperidone in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Area Under Curve (AUClast, AUCinf) and maximum concentration (Cmax) (time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.