SchizophreniaPhase 1NCT00791284
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
A Phase 1 study testing Intermediate release (IR) Paliperidone in people with Schizophrenia and Hepatic Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal hepatic function, 2) to document the plasma protein binding and disposition of the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Hepatic Impairment
- What is being tested?
- Intermediate release (IR) Paliperidone
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2004
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with normal hepatic function:Normotensive at screening, with supine (5 minutes) blood pressure between the range of 95 to 160 mmHg systolic, inclusive, and 55 to 95 mmHg diastolic, inclusive, demographically comparable to the hepatic impairment group with respect to age, weight, sex, and ethnicity and healthy on the basis of a prestudy physical examination, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 3 weeks before study drug administration. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's reference ranges, the patient can be included only if the investigator judges that the deviations are not clinically significant
- Patients with moderate hepatic impairment: Blood pressure controlled and stable on antihypertensive agents, stable hepatic disease with laboratory and clinical findings that support the diagnosis of hepatic impairment, otherwise healthy on the basis of a prestudy physical examination, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 3 weeks before study drug administration. Patients with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Patients with stable, mild, chronic concurrent diseases, such as degenerative joint disease, Type II diabetes, or thyroid conditions requiring thyroid replacement therapy or surgery, may be included. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's references ranges, the patient can be included only if the investigator judges that the deviations are not clinically significant. Laboratory results related to the patient's underlying condition may be outside of the normal ranges. (Serum bilirubin, albumin, and prothrombin time will be assessed individually)
- Total score of Child-Pugh's classification will be between 7 and 9, inclusive
- Concomitant medications to treat underlying disease states or medical conditions related to hepatic insufficiency are allowed. Patients have to be on a stable dose of medication and/or treatment regimen 2 months before the study, as well as during the study.
Who cannot join
- Patients with normal hepatic function:Has any significant history or presence of hepatic disease or has positive serology result for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (as determined by a multi-antigen enzyme immunoassay)
- At screening, sustained drops in systolic (>20 mmHg) or diastolic (>10 mmHg) blood pressure after standing for at least 2 minutes which are not associated with an increase in pulse rate of >15 beats per minute
- Is taking, or has taken, any prescribed or over-the-counter drug (including vitamins and herbal supplements) within 2 weeks before study drug administration (with the exception of paracetamol, hormonal contraceptives, and hormone replacement therapy)
- Patients with moderate hepatic impairment: Has any clinically significant laboratory abnormality except those parameters influenced by hepatic impairment, has a score of 3 or 4 for hepatic encephalopathy as determined by the result of the Number Connection Test, has severe ascites and/or pleural effusion, has serology result positive for HBsAg, has acute exacerbation of liver disease, as indicated by worsening clinical signs of hepatic impairment, or by an increase of more than 50% in total bilirubin or prothrombin time in the preceding 3 months (as far as information is available).
About this study
Official title: Pharmacokinetics of Paliperidone in Subjects With Moderate Hepatic Impairment as Compared to Subjects With Normal Hepatic Function.
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal hepatic function, 2) to document the plasma protein binding and disposition of the enantiomers of paliperidone, and 3) to evaluate the tolerability and safety profile of IR paliperidone in both patient populations.
Read the detailed description
This is a single-dose, parallel-group, open-label, single-center, Phase 1 study of immediate release (IR) paliperidone in patients having either normal or moderately-impaired hepatic function. The groups, which will consist of 10 patients each, will be demographically matched with respect to age, weight, sex, and ethnicity. The study will consist of a screening period of up to 3 weeks and an open-label, single-dose treatment period (Days 1 through 5). On Day 1, a single dose of 1 mg Intermediate Release (IR) paliperidone oral solution will be administered after a fast of at least 10 hours; patients will continue to fast for 4 hours following study drug administration. The 96-hour follow-up will consist of serial sample collections of blood and urine for pharmacokinetic analysis and safety and tolerability assessments. Patients will remain confined to the study site through the 72-hour pharmacokinetics sampling and will consume standard institutional meals while in the study site. Patients will be released after the 72-hour sampling, then will return to the study site on Day 5 before the 96-hour pharmacokinetics sampling; end-of-study procedures will be performed immediately thereafter. Currently, pharmacokinetic data are available after oral IR and Extended Release (ER) formulations of paliperidone were administered to healthy patients and to patients with schizophrenia who had normal hepatic function. No pharmacokinetic information on paliperidone in patients with hepatic impairment has been obtained. The target population for paliperidone comprises schizophrenic patients. Because some patients in the target population might be hepatically impaired, pharmacokinetic information in this population is helpful. This single-dose pharmacokinetic study will collect information in patients with normal hepatic function and in patients with moderate hepatic impairment to provide clinical dosing information/recommendations for patients with hepatic impairment. Safety and tolerability will be monitored. A single dose of 1 mg intermediate release (IR) paliperidone oral solution
- Conditions
- Schizophrenia, Hepatic Impairment
- Being tested
- Intermediate release (IR) Paliperidone
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, intermediate release (IR) Paliperidone
- Medical subject headings
- Schizophrenia, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate release (IR) PaliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the single-dose pharmacokinetics of IR paliperidone after oral administration to patients with moderate hepatic impairment as compared to patients with normal hepatic function
Secondary outcomes (1)
To document the plasma protein binding and disposition of the enantiomers of paliperidone and to evaluate the tolerability and safety profile of IR paliperidone in both patient populations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startAug 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791284
- Sponsor's protocol ID
- CR004204
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Paliperidone in Subjects With Moderate Hepatic Impairment as Compared to Subjects With Normal Hepatic Function.
- ClinicalTrials.gov ID
- NCT00791284
- Acronym / sponsor ID
- CR004204
- Conditions
- Schizophrenia, Hepatic Impairment
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, intermediate release (IR) Paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 14 Nov 2008 (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.
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal hepatic function, 2) to document the plasma protein binding and disposition of the enantiomers of paliperidone, and 3) to evaluate the tolerability and safety profile of IR paliperidone in both patient populations.
Detailed description
This is a single-dose, parallel-group, open-label, single-center, Phase 1 study of immediate release (IR) paliperidone in patients having either normal or moderately-impaired hepatic function. The groups, which will consist of 10 patients each, will be demographically matched with respect to age, weight, sex, and ethnicity. The study will consist of a screening period of up to 3 weeks and an open-label, single-dose treatment period (Days 1 through 5). On Day 1, a single dose of 1 mg Intermediate Release (IR) paliperidone oral solution will be administered after a fast of at least 10 hours; patients will continue to fast for 4 hours following study drug administration. The 96-hour follow-up will consist of serial sample collections of blood and urine for pharmacokinetic analysis and safety and tolerability assessments. Patients will remain confined to the study site through the 72-hour pharmacokinetics sampling and will consume standard institutional meals while in the study site. Patients will be released after the 72-hour sampling, then will return to the study site on Day 5 before the 96-hour pharmacokinetics sampling; end-of-study procedures will be performed immediately thereafter. Currently, pharmacokinetic data are available after oral IR and Extended Release (ER) formulations of paliperidone were administered to healthy patients and to patients with schizophrenia who had normal hepatic function. No pharmacokinetic information on paliperidone in patients with hepatic impairment has been obtained. The target population for paliperidone comprises schizophrenic patients. Because some patients in the target population might be hepatically impaired, pharmacokinetic information in this population is helpful. This single-dose pharmacokinetic study will collect information in patients with normal hepatic function and in patients with moderate hepatic impairment to provide clinical dosing information/recommendations for patients with hepatic impairment. Safety and tolerability will be monitored. A single dose of 1 mg intermediate release (IR) paliperidone oral solution
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with normal hepatic function:Normotensive at screening, with supine (5 minutes) blood pressure between the range of 95 to 160 mmHg systolic, inclusive, and 55 to 95 mmHg diastolic, inclusive, demographically comparable to the hepatic impairment group with respect to age, weight, sex, and ethnicity and healthy on the basis of a prestudy physical examination, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 3 weeks before study drug administration. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's reference ranges, the patient can be included only if the investigator judges that the deviations are not clinically significant
- Patients with moderate hepatic impairment: Blood pressure controlled and stable on antihypertensive agents, stable hepatic disease with laboratory and clinical findings that support the diagnosis of hepatic impairment, otherwise healthy on the basis of a prestudy physical examination, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 3 weeks before study drug administration. Patients with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Patients with stable, mild, chronic concurrent diseases, such as degenerative joint disease, Type II diabetes, or thyroid conditions requiring thyroid replacement therapy or surgery, may be included. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's references ranges, the patient can be included only if the investigator judges that the deviations are not clinically significant. Laboratory results related to the patient's underlying condition may be outside of the normal ranges. (Serum bilirubin, albumin, and prothrombin time will be assessed individually)
- Total score of Child-Pugh's classification will be between 7 and 9, inclusive
- Concomitant medications to treat underlying disease states or medical conditions related to hepatic insufficiency are allowed. Patients have to be on a stable dose of medication and/or treatment regimen 2 months before the study, as well as during the study.
Key exclusion criteria (4 listed)
- Patients with normal hepatic function:Has any significant history or presence of hepatic disease or has positive serology result for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (as determined by a multi-antigen enzyme immunoassay)
- At screening, sustained drops in systolic (>20 mmHg) or diastolic (>10 mmHg) blood pressure after standing for at least 2 minutes which are not associated with an increase in pulse rate of >15 beats per minute
- Is taking, or has taken, any prescribed or over-the-counter drug (including vitamins and herbal supplements) within 2 weeks before study drug administration (with the exception of paracetamol, hormonal contraceptives, and hormone replacement therapy)
- Patients with moderate hepatic impairment: Has any clinically significant laboratory abnormality except those parameters influenced by hepatic impairment, has a score of 3 or 4 for hepatic encephalopathy as determined by the result of the Number Connection Test, has severe ascites and/or pleural effusion, has serology result positive for HBsAg, has acute exacerbation of liver disease, as indicated by worsening clinical signs of hepatic impairment, or by an increase of more than 50% in total bilirubin or prothrombin time in the preceding 3 months (as far as information is available).
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 |
|---|---|---|
| Intermediate release (IR) Paliperidone | Drug | – |
Primary outcome
To investigate the single-dose pharmacokinetics of IR paliperidone after oral administration to patients with moderate hepatic impairment as compared to patients with normal hepatic function
1 secondary outcome
To document the plasma protein binding and disposition of the enantiomers of paliperidone and to evaluate the tolerability and safety profile of IR paliperidone in both patient populations
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 8 Jun 2011.
- A study of the pharmacokinetics of paliperidone in volunteers with normal or impaired liver functionLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intermediate release (IR) Paliperidone in people with Schizophrenia and Hepatic Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
To investigate the single-dose pharmacokinetics of IR paliperidone after oral administration to patients with moderate hepatic impairment as compared to patients with normal hepatic function. 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 8 Jun 2011.