SchizophreniaPhase 1NCT02765555
First in Man Study of Safety, Tolerability and PK Profile of RBP-7000
A Phase 1 study testing RBP-7000 in people with Schizophrenia, run by Indivior Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- RBP-7000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2010
- 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 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of paranoid, residual, or undifferentiated schizophrenia in a documented letter from the subject's psychiatrist or primary care provider.
- Clinically stable subjects (subjects whom the Principal Investigator (PI) established by medical record or by history from the subject and at least one reliable informant who resides with the subject, that the subject has been clinically stable for at least 60 days without hospitalization) will be eligible to participate in the study.
- Subjects with a body mass index (BMI) of 18 to 33 kg/m2 inclusive and weighing at least 49.9 kg are eligible for entry.
- Subjects who have given written informed consent.
Who cannot join
- Subjects taking any risperidone product in the last 60 days prior to study screening.
- Subjects with a history of cancer (excluding resected basal cell or squamous cell carcinoma of the skin) unless they have been disease free for ≥ 5 years.
- Subjects with another active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. This includes, but is not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions including, but not limited to, history of heart attack, brain injury, low blood pressure and clinically significant irregular heartbeat.
- Subjects with known diagnosis of type 1 or 2 diabetes or subjects with an abnormal Hemoglobin A1c (HbA1c) at screening.
- Subjects with clinically significant co-morbidities that could affect near-term survival.
- Subjects treated with any investigational drug within 30 days beginning study screening.
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- Subjects with significant traumatic injury, major surgery or open biopsy within the past 4 weeks.
- Subjects receiving opioid or opioid-containing analgesics.
- Subjects consuming > 1 alcoholic drink per day within the last 30 days (defined as one ounce of 80 proof spirits, 12 ounces of beer, or 4 ounces of wine).
- Subjects with prior allergic reactions or sensitivities to any component of RBP-7000.
- Subjects with other concurrent uncontrolled illness that may interfere with his or her ability to participate in the trial.
- Subjects with other known contraindications or sensitivity to risperidone or other components of RBP-7000.
- Women with a positive pregnancy test at screening. Women of childbearing potential, who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions, (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence. Should a female subject become sexually active, she must agree to use a double barrier method or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- . Subjects with a positive urine drug screen for opiates, cocaine, amphetamines, methadone, marijuana, barbiturates, benzodiazepines, methamphetamine, phencyclidine, and tricyclic antidepressants unless the positive screen is determined to be secondary to an allowable concomitant medication.
- Subjects with epilepsy or other seizure disorders, Parkinson's disease, or dementia.
- Subjects taking buproprion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine.
- Subjects taking clozapine, phenothiazines, or haloperidol.
- Subjects taking serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) in the 30 days prior to beginning study screening.
- . Subjects taking medications, in addition to those listed above, which may be expected to significantly interfere with the metabolism or excretion of risperidone and/or 9-hydroxyrisperidone, that may be associated with a significant drug interaction with risperidone, or may pose a significant risk to subjects' participation in the study.
- Subjects who have been previously enrolled into the study.
- Subjects who are unable, in the opinion of the Principal Investigator, to comply fully with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Center, Single Dose, Phase 1, First in Man Study of the Safety, Tolerability and Pharmacokinetic Profile of RBP-7000
The purpose of this study is to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone.
Read the detailed description
Twelve subjects with stable schizophrenia will be enrolled. The expected duration of participation is 88 days which includes at least a 2 days screening and an 85 day treatment period (15 -day inpatient stay in the clinical unit and an additional 70-day outpatient period, including the Day 85 end of study follow up or early termination visit. Visits will occur approximately weekly during the outpatient period.
Neurological and clinical symptom assessments (Positive and Negative Syndrome Scale [PANSS], Clinical Global Impressions-Schizophrenic Specific [CGI-SCH], Simpson-Angus Scale [SAS], Barnes Akathisia Scale [BAS], and Columbia-Suicide Severity Rating Scale [C-SSRS]) will be conducted at screening, on the day of admission to the clinical unit (Day -1), and at each post-dose visit throughout the study including the follow-up visit. Scale results will be reviewed by the Principal Investigator. The Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia will be performed at screening and at each post-dose visit throughout the study including the end of study follow-up visit. CYP-2D6 genotyping will be conducted at screening. Tolerability will be measured using SAS, which will be conducted as described above.
Blood samples to assess the PK parameters will be taken from pre-dose until approximately 84 days post-dose.
End of study procedures will be conducted on follow-up Day 85 (84 days post-dose) or early termination (ET) to assess any adverse events (AEs) that were ongoing at the last visit, any new AEs that have developed, and for measurement of safety parameters.
- Conditions
- Schizophrenia
- Being tested
- RBP-7000
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBP-7000Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| RBP-7000 | Experimental | All subjects that meet initial study entry criteria will receive a test dose of 0.25mg of oral risperidone. Subjects who continue to be eligible will return to the clinical unit in one week and receive a single dose of 60mg RBP-7000 after a 2 hour fast. Subjects will remain in the clinical unit for 14 days, then return for 10 additional weeks after discharge. Receives: Drug: RBP-7000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse and serious adverse events after a single injection of RBP-7000
Adverse events, serious adverse events, discontinuations due to AEs, local injection site tolerability, vital signs, physical examinations, laboratory results, use of concomitant medications, clinical symptom assessments, 12-lead ECGs
Measured: Day 1-Day 85
Maximum plasma concentration (Cmax) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Measured: Pre-Dose to 84 days post-dose
Time of occurrence of Cmax (Tmax) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Measured: Pre-Dose to 84 days post-dose
Area under the plasma concentration versus time curve (AUC) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Measured: Pre-Dose to 84 days post-dose
AUC last after a single injection of RBP-7000
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Measured: Day 85
C last
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Measured: Day 85
T last
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Measured: Day 85
Apparent elimination rate constant (AUC0-∞, λz)
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Measured: Pre-dose to 84 days post-dose
Half life (T1/2)
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Measured: Pre-dose to 84 days post-dose
Secondary outcomes (1)
Cmax versus RISPERDAL® CONSTA® historical data
The distribution of RBP-7000 compared to those obtained in a previous single-dose study of RISPERDAL® CONSTA®.
Measured: Pre-Dose to 84 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 posted6 May 2016 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765555
- Sponsor's protocol ID
- RB-US-09-0007
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Center, Single Dose, Phase 1, First in Man Study of the Safety, Tolerability and Pharmacokinetic Profile of RBP-7000
- ClinicalTrials.gov ID
- NCT02765555
- Acronym / sponsor ID
- RB-US-09-0007
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 May 2016 (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 to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone.
Detailed description
Twelve subjects with stable schizophrenia will be enrolled. The expected duration of participation is 88 days which includes at least a 2 days screening and an 85 day treatment period (15 -day inpatient stay in the clinical unit and an additional 70-day outpatient period, including the Day 85 end of study follow up or early termination visit. Visits will occur approximately weekly during the outpatient period.
Neurological and clinical symptom assessments (Positive and Negative Syndrome Scale [PANSS], Clinical Global Impressions-Schizophrenic Specific [CGI-SCH], Simpson-Angus Scale [SAS], Barnes Akathisia Scale [BAS], and Columbia-Suicide Severity Rating Scale [C-SSRS]) will be conducted at screening, on the day of admission to the clinical unit (Day -1), and at each post-dose visit throughout the study including the follow-up visit. Scale results will be reviewed by the Principal Investigator. The Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia will be performed at screening and at each post-dose visit throughout the study including the end of study follow-up visit. CYP-2D6 genotyping will be conducted at screening. Tolerability will be measured using SAS, which will be conducted as described above.
Blood samples to assess the PK parameters will be taken from pre-dose until approximately 84 days post-dose.
End of study procedures will be conducted on follow-up Day 85 (84 days post-dose) or early termination (ET) to assess any adverse events (AEs) that were ongoing at the last visit, any new AEs that have developed, and for measurement of safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RBP-7000 | Experimental | Drug: RBP-7000All subjects that meet initial study entry criteria will receive a test dose of 0.25mg of oral risperidone. Subjects who continue to be eligible will return to the clinical unit in one week and receive a single dose of 60mg RBP-7000 after a 2 hour fast. Subjects will remain in the clinical unit for 14 days, then return for 10 additional weeks after discharge. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of paranoid, residual, or undifferentiated schizophrenia in a documented letter from the subject's psychiatrist or primary care provider.
- Clinically stable subjects (subjects whom the Principal Investigator (PI) established by medical record or by history from the subject and at least one reliable informant who resides with the subject, that the subject has been clinically stable for at least 60 days without hospitalization) will be eligible to participate in the study.
- Subjects with a body mass index (BMI) of 18 to 33 kg/m2 inclusive and weighing at least 49.9 kg are eligible for entry.
- Subjects who have given written informed consent.
Key exclusion criteria (21 listed)
- Subjects taking any risperidone product in the last 60 days prior to study screening.
- Subjects with a history of cancer (excluding resected basal cell or squamous cell carcinoma of the skin) unless they have been disease free for ≥ 5 years.
- Subjects with another active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. This includes, but is not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions including, but not limited to, history of heart attack, brain injury, low blood pressure and clinically significant irregular heartbeat.
- Subjects with known diagnosis of type 1 or 2 diabetes or subjects with an abnormal Hemoglobin A1c (HbA1c) at screening.
- Subjects with clinically significant co-morbidities that could affect near-term survival.
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 |
|---|---|---|
| RBP-7000Single dose | Drug | RBP-7000 |
Primary outcome
Incidence of treatment emergent adverse and serious adverse events after a single injection of RBP-7000
Time frame: Day 1-Day 85
Adverse events, serious adverse events, discontinuations due to AEs, local injection site tolerability, vital signs, physical examinations, laboratory results, use of concomitant medications, clinical symptom assessments, 12-lead ECGs
Maximum plasma concentration (Cmax) after a single injection of RBP-7000
Time frame: Pre-Dose to 84 days post-dose
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Time of occurrence of Cmax (Tmax) after a single injection of RBP-7000
Time frame: Pre-Dose to 84 days post-dose
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Area under the plasma concentration versus time curve (AUC) after a single injection of RBP-7000
Time frame: Pre-Dose to 84 days post-dose
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
AUC last after a single injection of RBP-7000
Time frame: Day 85
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
C last
Time frame: Day 85
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
T last
Time frame: Day 85
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Apparent elimination rate constant (AUC0-∞, λz)
Time frame: Pre-dose to 84 days post-dose
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Half life (T1/2)
Time frame: Pre-dose to 84 days post-dose
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
1 secondary outcome
Cmax versus RISPERDAL® CONSTA® historical data
Time frame: Pre-Dose to 84 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 6 May 2016.
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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.
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 RBP-7000 in people with Schizophrenia, run by Indivior 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 4 inclusion and 21 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 6 May 2016. 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?
Incidence of treatment emergent adverse and serious adverse events after a single injection of RBP-7000 (time frame: Day 1-Day 85). The study lists 9 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 6 May 2016.