SchizophreniaPhase 1NCT01206517
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
A Phase 1 study testing Asenapine 2.5 mg, Asenapine 5 mg and Asenapine 10 mg in people with Schizophrenia and Bipolar I Disorder, run by Organon and Co.
Trial summary
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- What is being tested?
- Asenapine 2.5 mg, Asenapine 5 mg and Asenapine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2010to 4 Aug 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For participants in Cohorts 1, 2, 3b, 3c and 3d:
- Diagnosis of schizophrenia or bipolar I disorder
- A schizophrenic participant must have a diagnosis of current schizophrenia of paranoid disorganized, catatonic, or undifferentiated subtype as determined by a structured clinical interview at screening
- A bipolar I disorder participant must have a primary diagnosis of bipolar I disorder, current episode manic, or mixed as determined by a structured clinical interview at screening
- For participants in Cohort 3a:
- Documented history of schizophrenia, bipolar disorder, autism, conduct disorder, oppositional defiant disorder, or any condition for which the chronic use of antipsychotic medication (e.g, risperidone, olanzapine, aripiprazole, haloperidol) was warranted and/or administered
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- All participants:
- Must be at least 10 and not older than 17 years of age at the day of first asenapine dosing (Cohort 3); for Cohort 1 and 2 subjects should be at least 10 and not older than 11 years of age at the day of first asenapine dosing
- Must be able and willing to sign an informed assent as required by local regulations before study participation and able to adhere to dose and visit schedules or their parent/authorized legal representative(s) should be able and willing to sign an informed consent, and should be fluent in the language of the informed consent
- Must have a caregiver or an identified responsible person who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures
- Must be fluent in the language of the investigator, trial staff (including raters) and the informed assent
- Must be willing to discontinue all psychotropic medication during the treatment period except for those specified in the protocol
- Have discontinued the use of strong inhibitors or inducers of cytochrome P450 (CYP)1A2 and/or CYP2D6 (e.g. fluvoxamine, citalopram, fluoxetine, paroxetine, omeprazole, and rifampicin) and beta-blockers, applying a washout period of 5 half lives or 7 days, whichever is longer, AND be stabilized on non-interacting alternative medication (i.e. medication not interacting with asenapine pharmacokinetics) for 2 weeks prior to baseline if their medical condition requires this
- Clinical laboratory tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator, after discussion with the Sponsor and following agreement of the Sponsor's medical monitor
- Screening 12 lead electrocardiogram (ECG) conduction intervals and vital signs recordings (oral body temperature, systolic/diastolic blood pressure and pulse rate) must be clinically acceptable according to the investigator, after discussion with the Sponsor and following agreement of the Sponsor's medical monitor
- If male, and non-vasectomized, must agree to use a condom with spermicide (when marketed in the country) or abstain from sexual intercourse, during the trial and for 3 months after stopping the medication
- Female participants must:
- If unsterilized, have used a medically accepted method of contraception for 3 months (or abstained from sexual intercourse) prior to the screening period, and agree to use a medically accepted method of contraception during the trial (including the screening period prior to receiving trial medication) and for 2 months after stopping the trial medication. An acceptable method of contraception includes one of the following:
- stable oral, transdermal, injectable, or sustained-release vaginal hormonal contraceptive regimen without breakthrough uterine bleeding for 3 months prior to Screening; in addition, during study use of condom and/or spermicide (when marketed in the country)
- intrauterine device (inserted at least 2 months prior to Screening visit); in addition, during study use of condom and/or spermicide (when marketed in the country)
- Note: Vasectomy of the partner is not considered sufficient contraception and one of the 2 methods listed above must be used
- Females who are not currently sexually active must also consent to use one of these accepted methods of contraception should they become sexually active while participating in the study
- condom (male or female) with spermicide (when marketed within the country),
- diaphragm or cervical cap with spermicide (when marketed within the country) and condom (male),
Who cannot join
- The participant will be excluded from entry if ANY of the criteria listed below are met at baseline
- The participant:
- Is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding
- In the opinion of the investigator, will not be able to participate optimally in the study
- Has an uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic, gastrointestinal or cerebrovascular disease, or malignancy) that may interfere with the interpretation of pharmacokinetic, safety and tolerability evaluations in the opinion of the investigator
- Has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial
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- Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Has a positive screen for drugs with a high potential for abuse (during the Screening period or clinical conduct of the trial)
- Has a history of psychiatric or personality disorders that in the opinion of the investigator and sponsor, affects the subject's ability to participate in the trial
- Has a history of neuroleptic malignant syndrome
- Has a diagnosis of mental retardation or organic brain disorder
- Has a primary diagnosis other than schizophrenia or bipolar I disorder, current episode manic or mixed, that is primarily responsible for current symptoms and functional impairment; this exclusion is not applicable to participants in Cohort 3a
- Has a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse
- Has a current (past 6 months) substance and alcohol abuse or dependence (excluding nicotine and caffeine)
- Has a history of tardive dyskinesia or tardive dystonia
- If has attention-deficit/hyperactivity disorder (ADHD), has not been on a stable dose of stimulants (e.g. amphetamines, methylphenidate) for the last 3 months (participants who have not taken any stimulants in the last month will not be excluded)
- Has a history of alcohol or drug abuse in the past 2 years
- Has donated blood in the past 60 days
- Has previously received asenapine
- Is at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical judgment
- Report at Screening, suicidal ideation, or suicidal behavior in the past 6 months
- Is currently participating in another clinical study or have participated in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline
- Is part of the study staff personnel or family members of the study staff personnel
- Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial
- Smokes more than 10 cigarettes or equivalent tobacco use per day
- Has a history of malignancy
About this study
Official title: A Sequential Groups, Open Label, Rising Multiple Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).
- Conditions
- Schizophrenia, Bipolar I Disorder
- Being tested
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Keywords
- asenapine, pediatric schizophrenia, bipolar I disorder
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asenapine 2.5 mgDrug
Also called SCH 900274, Org 5222
Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7.
Asenapine 5 mgDrug
Also called SCH 900274, Org 5222
Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7.
Asenapine 10 mgDrug
Also called SCH 900274, Org 5222
Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants 10 or 11 years of age Receives: Drug: Asenapine 2.5 mg |
| Cohort 2 | Experimental | Participants 10 or 11 years of age Receives: Drug: Asenapine 5 mg |
| Cohort 3a-d | Experimental | Cohort 3a: Participants 10 or 11 years of age
Cohort 3b: Participants 12 or 13 years of age
Cohort 3c: Participants 14 or 15 years of age
Cohort 3d: Participants 16 or 17 years of age Receives: Drug: Asenapine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Asenapine
Cmax is the peak plasma concentration following a dose of the study drug.
Measured: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Time to Maximum Plasma Concentration (Tmax) of Asenapine
tmax is the time from dosing to maximum plasma drug concentration levels.
Measured: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine
AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.
Measured: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Terminal Phase (Elimination) Half-life (t1/2) of Asenapine
Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.
Measured: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study start18 Jul 2010
- Primary completion4 Aug 2011
- Study completion4 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206517
- Sponsor's protocol ID
- P06522
- Status last verified
- Feb 2022
- First submitted
- 17 Sep 2010
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Groups, Open Label, Rising Multiple Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT01206517
- Acronym / sponsor ID
- P06522
- Conditions
- Schizophrenia, Bipolar I Disorder
- Keywords
- asenapine, pediatric schizophrenia, bipolar I disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2010 (actual)
- Primary completion
- 4 Aug 2011 (actual)
- Study completion
- 4 Aug 2011 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Posted 21 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Asenapine 2.5 mgParticipants 10 or 11 years of age |
| Cohort 2 | Experimental | Drug: Asenapine 5 mgParticipants 10 or 11 years of age |
| Cohort 3a-d | Experimental | Drug: Asenapine 10 mgCohort 3a: Participants 10 or 11 years of age Cohort 3b: Participants 12 or 13 years of age Cohort 3c: Participants 14 or 15 years of age Cohort 3d: Participants 16 or 17 years of age |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- Diagnosis of schizophrenia or bipolar I disorder
- A schizophrenic participant must have a diagnosis of current schizophrenia of paranoid disorganized, catatonic, or undifferentiated subtype as determined by a structured clinical interview at screening
- A bipolar I disorder participant must have a primary diagnosis of bipolar I disorder, current episode manic, or mixed as determined by a structured clinical interview at screening
- Documented history of schizophrenia, bipolar disorder, autism, conduct disorder, oppositional defiant disorder, or any condition for which the chronic use of antipsychotic medication (e.g, risperidone, olanzapine, aripiprazole, haloperidol) was warranted and/or administered
- Must be at least 10 and not older than 17 years of age at the day of first asenapine dosing (Cohort 3); for Cohort 1 and 2 subjects should be at least 10 and not older than 11 years of age at the day of first asenapine dosing
Key exclusion criteria (26 listed)
- The participant will be excluded from entry if ANY of the criteria listed below are met at baseline
- Is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding
- In the opinion of the investigator, will not be able to participate optimally in the study
- Has an uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic, gastrointestinal or cerebrovascular disease, or malignancy) that may interfere with the interpretation of pharmacokinetic, safety and tolerability evaluations in the opinion of the investigator
- Has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial
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 |
|---|---|---|
| Asenapine 2.5 mgAlso: SCH 900274, Org 5222Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7. | Drug | Cohort 1 |
| Asenapine 5 mgAlso: SCH 900274, Org 5222Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7. | Drug | Cohort 2 |
| Asenapine 10 mgAlso: SCH 900274, Org 5222Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12. | Drug | Cohort 3a-d |
Primary outcome
Maximum Plasma Concentration (Cmax) of Asenapine
Time frame: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Cmax is the peak plasma concentration following a dose of the study drug.
Time to Maximum Plasma Concentration (Tmax) of Asenapine
Time frame: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
tmax is the time from dosing to maximum plasma drug concentration levels.
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine
Time frame: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.
Terminal Phase (Elimination) Half-life (t1/2) of Asenapine
Time frame: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Asenapine 2.5 mg, Asenapine 5 mg and Asenapine 10 mg in people with Schizophrenia and Bipolar I Disorder, run by Organon and Co.
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 24 inclusion and 26 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 23 May 2024. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) of Asenapine (time frame: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)). 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 23 May 2024.