SchizophreniaPhase 1NCT01592110
A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia
A Phase 1 study testing risperidone-SABER and ZX003:risperidone-SABER and the DosePro System in people with Schizophrenia, run by Zogenix, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone-SABER and ZX003:risperidone-SABER and the DosePro System
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years of age or older.
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as per DSM-IV criteria in the past 6 months or more, dependent on diagnosis.
- Currently on maintenance antipsychotic medication (i.e., patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
- Body Mass Index (BMI) (kg/m2) ≥ 20 and ≤ 40.
- Female patients with:
- Non-childbearing potential (surgically sterile [hysterectomy]) or post-menopausal ≥ 2 years -OR-
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- Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in the 12-lead electrocardiogram (ECG).
- No clinically significant findings from a vital signs measurement.
- Be informed of the nature of the study and give written consent prior to initiating any study procedure.
Who cannot join
- Have known or suspected carcinoma.
- Have known presence or history of renal or hepatic insufficiency.
- Have known history, hypersensitivity or idiosyncratic reaction (including dystonias) to risperidone, paliperidone, and/or any other drug substance with similar activity.
- Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening.
- Have a history of epilepsy or risk of having seizures.
- Are pregnant, lactating, or likely to become pregnant during the study.
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- Have taken an antipsychotic depot product (including investigational products) within the 60 days prior to Screening.
- Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
- Have a positive alcohol breathalyzer test at Screening or Admission.
- Have a positive Screening test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Have a positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Admission.
- Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee).
- Are unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Admission until End-of-Study.
- Excessive smoking as judged by the Investigator
- Donation of blood (> 500 mL) or blood products within 2 months (56 days) prior to Admission.
- Have used any concomitant medications significantly impacting CYP2D6 (moderate and strong inducers/inhibitors), including but not limited to those outlined in Appendix 1, within 14 days or 5 half-lives (whichever is longer) prior to Admission. Medications judged to not interact with risperidone may be continued at the discretion of the Investigator and in accordance with the protocol requirements for tapering and wash-out.
- Are unwilling to abstain from vigorous exercise (as judged by the Investigator) from 48 hours prior to Admission until End-of-Study.
- Are unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
- Are unlikely to comply with the protocol requirements, instructions and study- related restrictions (e.g., uncooperative attitude, inability to return for out-patient visits or improbability of completing the clinical study).
- Have previously been enrolled in this clinical study.
- Are unable to tolerate the oral risperidone challenge on Screening Day -3.
- Are unable to stabilize on antipsychotic medication tapering during the Screening period.
- Note that "Admission" in the above criteria refers to Admission and Qualification which occurs on day -4 for Cohort 1 and Day -6 for Cohorts 2 and 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glendale Adventist Medical Center
Glendale, California, 91206
About this study
Official title: A Pilot, Open-Label, Non-Randomized, Single Ascending Dose, Safety and Pharmacokinetic Trial With Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
Read the detailed description
This is an open-label, single ascending dose (SAD), safety and PK study in patients with chronic, stable schizophrenia or schizoaffective disorder. Patients will participate in the study for a total of up to 10 weeks for Cohorts 1-3, including a Screening period of up to 35 days and a study treatment period of 35 days, and up to 14 weeks for Cohort 4, including a Screening period of up to 35 days and a study treatment period of 63 days. Patients will be assigned to one of four cohorts, and will receive a single dose of 25 mg, 50 mg or 100 mg (100 mg/mL concentration) administered as a single subcutaneous (SC) injection or via the DosePro Needle-Free Delivery System.
- Conditions
- Schizophrenia
- Being tested
- risperidone-SABER, ZX003:risperidone-SABER and the DosePro System
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone-SABERDrug
25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL
ZX003:risperidone-SABER and the DosePro SystemOther
50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System
risperidone-SABERDrug
50 mg of risperidone-SABER administered as a SC injection of 0.5 mL
Risperidone-SABERDrug
100 mg of risperidone-SABER administered as a SC injection of 1.0 mL
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 25 mg of risperidone-SABER administered as a SC injection of 0.25 mL (100 mg/mL concentration) in the abdominal region Receives: Drug: risperidone-SABER |
| Cohort 2 | Experimental | 50 mg of ZX003 (risperidone-SABER-DosePro) administered as 0.5 mL (100 mg/mL concentration) via the DosePro Needle-free Delivery System in the abdominal region Receives: Other: ZX003:risperidone-SABER and the DosePro System |
| Cohort 3 | Experimental | 50 mg of risperidone-SABER administered as a SC injection of 0.5 mL (100 mg/mL concentration) in the abdominal region Receives: Drug: risperidone-SABER |
| Cohort 4 | Experimental | 100 mg of risperidone-SABER administered as a SC injection of 1.0 mL (100 mg/mL concentration) in the abdominal region Receives: Drug: Risperidone-SABER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER
Measured: Within 35 days post-dose
Maximum plasma concentration, time of maximum plasma concentration and area under the concentration time curve for risperidone, 9-OH risperidone and active moiety (risperidone + 9-OH risperidone)
Measured: Within 35 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionApr 2013
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lev G Gertsik, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592110
- Sponsor's protocol ID
- ZX003-1101
- Status last verified
- Jul 2013
- First submitted
- 1 May 2012
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Non-Randomized, Single Ascending Dose, Safety and Pharmacokinetic Trial With Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01592110
- Acronym / sponsor ID
- ZX003-1101
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 May 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 is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
Detailed description
This is an open-label, single ascending dose (SAD), safety and PK study in patients with chronic, stable schizophrenia or schizoaffective disorder. Patients will participate in the study for a total of up to 10 weeks for Cohorts 1-3, including a Screening period of up to 35 days and a study treatment period of 35 days, and up to 14 weeks for Cohort 4, including a Screening period of up to 35 days and a study treatment period of 63 days. Patients will be assigned to one of four cohorts, and will receive a single dose of 25 mg, 50 mg or 100 mg (100 mg/mL concentration) administered as a single subcutaneous (SC) injection or via the DosePro Needle-Free Delivery System.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: risperidone-SABER25 mg of risperidone-SABER administered as a SC injection of 0.25 mL (100 mg/mL concentration) in the abdominal region |
| Cohort 2 | Experimental | Other: ZX003:risperidone-SABER and the DosePro System50 mg of ZX003 (risperidone-SABER-DosePro) administered as 0.5 mL (100 mg/mL concentration) via the DosePro Needle-free Delivery System in the abdominal region |
| Cohort 3 | Experimental | Drug: risperidone-SABER50 mg of risperidone-SABER administered as a SC injection of 0.5 mL (100 mg/mL concentration) in the abdominal region |
| Cohort 4 | Experimental | Drug: Risperidone-SABER100 mg of risperidone-SABER administered as a SC injection of 1.0 mL (100 mg/mL concentration) in the abdominal region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients 18 years of age or older.
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as per DSM-IV criteria in the past 6 months or more, dependent on diagnosis.
- Currently on maintenance antipsychotic medication (i.e., patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
- Body Mass Index (BMI) (kg/m2) ≥ 20 and ≤ 40.
- Female patients with:
Key exclusion criteria (23 listed)
- Have known or suspected carcinoma.
- Have known presence or history of renal or hepatic insufficiency.
- Have known history, hypersensitivity or idiosyncratic reaction (including dystonias) to risperidone, paliperidone, and/or any other drug substance with similar activity.
- Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening.
- Have a history of epilepsy or risk of having seizures.
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 |
|---|---|---|
| risperidone-SABER25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL | Drug | Cohort 1 |
| ZX003:risperidone-SABER and the DosePro System50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System | Other | Cohort 2 |
| risperidone-SABER50 mg of risperidone-SABER administered as a SC injection of 0.5 mL | Drug | Cohort 3 |
| Risperidone-SABER100 mg of risperidone-SABER administered as a SC injection of 1.0 mL | Drug | Cohort 4 |
Primary outcome
Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER
Time frame: Within 35 days post-dose
Maximum plasma concentration, time of maximum plasma concentration and area under the concentration time curve for risperidone, 9-OH risperidone and active moiety (risperidone + 9-OH risperidone)
Time frame: Within 35 days post-dose
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 10 Nov 2022.
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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.
Lev G Gertsik, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing risperidone-SABER and ZX003:risperidone-SABER and the DosePro System in people with Schizophrenia, run by Zogenix, Inc. at 1 site 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 11 inclusion and 23 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 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER (time frame: Within 35 days post-dose). The study lists 2 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 10 Nov 2022.