SchizophreniaPhase 1NCT02768649
Single Ascending Dose Study of RBP-7000
A Phase 1 study testing RBP-7000 and risperidone in people with Schizophrenia, run by Indivior Inc. at 1 site in United States.
Trial summary
The purpose of this study was to assess the safety and tolerability of injections of RBP-7000 in subjects with stable schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- RBP-7000 and risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with 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 PI established by medical record or by history from the subject and at least 1 reliable informant, that the subject had been clinically stable for at least 60 days without hospitalization).
- Subjects with body mass index (BMI) between 18 and 33 kg/m2 and weight of at least 49.9 kg.
- Subjects who gave written informed consent.
Who cannot join
- Subjects taking any risperidone product within 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 had been disease free for ≥ 5 years.
- Subjects with another active medical condition or organ disease that could have either compromised subject safety or interfered with the safety and/or outcome evaluation of the study drug. This included, but was not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions included, but were not limited to: history of heart attack, brain injury, low blood pressure, and clinically significant irregular heartbeat as interpreted by the PI.
- Subjects who were known to have acquired immune deficiency syndrome or to be human immunodeficiency virus (HIV) positive.
- Subjects with evidence or history of significant hepatic disorder, including acute or chronic hepatitis B and acute hepatitis C. Subjects with hepatitis C antibody and liver functions ≤ 1.5 times the ULN could be included in the study.
- Subjects with known diagnosis of type 1 or 2 diabetes or subjects with a clinically significant abnormal hemoglobin A1c (HbA1c) at screening as interpreted by the PI.
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- Subjects with clinically significant comorbidities that could affect near-term survival.
- Subjects treated with any investigational drug within the last 30 days prior to study screening.
- Subjects with significant traumatic injury, major surgery, or open biopsy within the last 4 weeks prior to study screening.
- Subjects receiving opioid or opioid-containing analgesics within the last 30 days prior to study screening.
- Subjects consuming > 1 alcoholic drink per day within the last 30 days prior to study screening (defined as 1 oz. of 80 proof spirits, 12 oz. of beer, or 4 oz. of wine).
- Subjects with prior allergic reactions, sensitivities, or other known contraindications to any component of RBP-7000 (i.e., risperidone, poly [DL-lactide-co-glycolide], or N-methylpyrrolidone).
- Subjects with other concurrent uncontrolled illness that may have interfered with the ability to participate in the study.
- Women with a positive pregnancy test at screening. Women of childbearing potential, who were 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, or an intrauterine device). Should a female subject become sexually active, she must have agreed to use a double-barrier method or barrier plus spermicide. A woman of childbearing potential was defined as any female who was less than 2 years post-menopausal or had not undergone a hysterectomy or surgical sterilization, e.g., bilateral tubal ligation or bilateral ovariectomy (oophorectomy). Females who were post-menopausal were confirmed by the follicle stimulating hormone (FSH) test at initial screening.
- Subjects with a positive urine drug screen for opioids, cocaine, amphetamines, methadone, marijuana, barbiturates, benzodiazepines, methamphetamine, phencyclidine, or tricyclic antidepressants unless the positive screen was determined to be secondary to an allowable concomitant medication.
- Subjects with epilepsy or other seizure disorders, Parkinson's disease, or dementia.
- Subjects taking bupropion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine within the last 30 days prior to study screening.
- Subjects taking clozapine, phenothiazines, aripiprazole, or haloperidol within the last 30 days prior to study screening.
- Subjects taking serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) within the last 30 days prior to study screening.
- Subjects taking medications, in addition to those listed above, which may have been expected to significantly interfere with the metabolism or excretion of risperidone and/or 9-hydroxyrisperidone that may have been associated with a significant drug interaction with risperidone, or may have posed a significant risk to subjects' participation in the study.
- Subjects who had been previously injected with RBP-7000 in this study. Subjects who were unable, in the opinion of the PI, to comply fully with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Single Center, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of RBP-7000 at Low, Medium, and High Doses
The purpose of this study was to assess the safety and tolerability of injections of RBP-7000 in subjects with stable schizophrenia
Read the detailed description
This was an open-label, single-center, Phase 1, single ascending dose study, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single SC injection of low, medium and high doses of RBP-7000 in subjects with clinically stable schizophrenia who were not taking risperidone. The design was a sequential cohort with treatment initiated in 3 cohorts after safety and tolerability at a lower dose were confirmed.
Eligible subjects received a single oral test dose of 0.25mg risperidone under medical supervision. Subjects who continued to be eligible were admitted to a residential unit for approximately 14 days, and received a single dose of RBP-7000. Subjects were discharged on Day 15 and returned to the clinical site weekly for approximately 10 weeks.
- Conditions
- Schizophrenia
- Being tested
- RBP-7000, risperidone
- 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
Sequential dosing of each cohort
risperidoneDrug
Also called test dose
All eligible subjects received a test dose of risperidone to ensure tolerability prior to dosing with RBP-7000.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Eligible subjects received a test dose of 0.25 risperidone prior to dosing with RBP-7000. Fifteen eligible subjects then received low dose RBP-7000 Receives: Drug: RBP-7000; Drug: risperidone |
| Cohort 2 | Experimental | After safety and tolerability review of the data from Day 1 to Day 15 of the low dose arm, 3 subjects were dosed in Cohort 2 with a higher dose of RBP-7000. A safety and tolerability review of the data from Day 1 to Day 15 was completed for the 3 subjects before the remaining 12 were dosed. Receives: Drug: RBP-7000; Drug: risperidone |
| Cohort 3 | Experimental | After safety and tolerability review of the data from Day 1 to Day 15 of the medium dose arm, 3 subjects were dosed in Cohort 3 with a higher dose of RBP-7000. A safety and tolerability review of the data from Day 1 to Day 15 was completed for the 3 subjects before the remaining 12 were dosed. Receives: Drug: RBP-7000; Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] after a subcutaneous injection of a single 60 mg, 90 mg, and 120 mg dose of risperidone in RBP-7000 in subjects with clinically stable schizophrenia
Adverse events, serious adverse events, and discontinuations due to AEs related to treatment.
Measured: Day 1 through Day 85
Secondary outcomes (5)
Maximum plasma concentration (Cmax) of risperidone and total risperidone
Blood samples for PK were collected and analyzed for concentration data of risperidone, 9-hydroxyrisperidone, and total risperidone throughout the study period
Measured: Day 0 through Day 85
Time of occurrence of Cmax (Tmax) of risperidone and total risperidone
Blood samples for PK were collected and analyzed for concentration-time data of risperidone, 9-hydroxyrisperidone, and total risperidone throughout the study period
Measured: Day 0 through time of last quantifiable concentration
Area under the plasma concentration versus time curve (AUC)
Area under the risperidone and total risperidone plasma concentration-time curves from time-zero to Day 85
Measured: Day 0 through Day 85
Observed terminal rate constant of risperidone and total risperidone (λz)
λz estimated by linear regression through at least 3 data points in the terminal phase of the log concentration-time profile
Measured: Day 0 through Day 85
Terminal half-life of risperidone and total risperidone (T1/2)
The observed terminal half-life of risperidone, 9-hydroxyrisperidone, and total risperidone was calculated
Measured: Day 0 through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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
- 45 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
- NCT02768649
- Sponsor's protocol ID
- RB-US-09-0008
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Single Center, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of RBP-7000 at Low, Medium, and High Doses
- ClinicalTrials.gov ID
- NCT02768649
- Acronym / sponsor ID
- RB-US-09-0008
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 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 was to assess the safety and tolerability of injections of RBP-7000 in subjects with stable schizophrenia
Detailed description
This was an open-label, single-center, Phase 1, single ascending dose study, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single SC injection of low, medium and high doses of RBP-7000 in subjects with clinically stable schizophrenia who were not taking risperidone. The design was a sequential cohort with treatment initiated in 3 cohorts after safety and tolerability at a lower dose were confirmed.
Eligible subjects received a single oral test dose of 0.25mg risperidone under medical supervision. Subjects who continued to be eligible were admitted to a residential unit for approximately 14 days, and received a single dose of RBP-7000. Subjects were discharged on Day 15 and returned to the clinical site weekly for approximately 10 weeks.
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: RBP-7000, Drug: risperidoneEligible subjects received a test dose of 0.25 risperidone prior to dosing with RBP-7000. Fifteen eligible subjects then received low dose RBP-7000 |
| Cohort 2 | Experimental | Drug: RBP-7000, Drug: risperidoneAfter safety and tolerability review of the data from Day 1 to Day 15 of the low dose arm, 3 subjects were dosed in Cohort 2 with a higher dose of RBP-7000. A safety and tolerability review of the data from Day 1 to Day 15 was completed for the 3 subjects before the remaining 12 were dosed. |
| Cohort 3 | Experimental | Drug: RBP-7000, Drug: risperidoneAfter safety and tolerability review of the data from Day 1 to Day 15 of the medium dose arm, 3 subjects were dosed in Cohort 3 with a higher dose of RBP-7000. A safety and tolerability review of the data from Day 1 to Day 15 was completed for the 3 subjects before the remaining 12 were dosed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with 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 PI established by medical record or by history from the subject and at least 1 reliable informant, that the subject had been clinically stable for at least 60 days without hospitalization).
- Subjects with body mass index (BMI) between 18 and 33 kg/m2 and weight of at least 49.9 kg.
- Subjects who gave written informed consent.
Key exclusion criteria (21 listed)
- Subjects taking any risperidone product within 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 had been disease free for ≥ 5 years.
- Subjects with another active medical condition or organ disease that could have either compromised subject safety or interfered with the safety and/or outcome evaluation of the study drug. This included, but was not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions included, but were not limited to: history of heart attack, brain injury, low blood pressure, and clinically significant irregular heartbeat as interpreted by the PI.
- Subjects who were known to have acquired immune deficiency syndrome or to be human immunodeficiency virus (HIV) positive.
- Subjects with evidence or history of significant hepatic disorder, including acute or chronic hepatitis B and acute hepatitis C. Subjects with hepatitis C antibody and liver functions ≤ 1.5 times the ULN could be included in the study.
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-7000Sequential dosing of each cohort | Drug | Cohort 1, Cohort 2, Cohort 3 |
| risperidoneAlso: test doseAll eligible subjects received a test dose of risperidone to ensure tolerability prior to dosing with RBP-7000. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] after a subcutaneous injection of a single 60 mg, 90 mg, and 120 mg dose of risperidone in RBP-7000 in subjects with clinically stable schizophrenia
Time frame: Day 1 through Day 85
Adverse events, serious adverse events, and discontinuations due to AEs related to treatment.
5 secondary outcomes
Maximum plasma concentration (Cmax) of risperidone and total risperidone
Time frame: Day 0 through Day 85
Time of occurrence of Cmax (Tmax) of risperidone and total risperidone
Time frame: Day 0 through time of last quantifiable concentration
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 0 through Day 85
Observed terminal rate constant of risperidone and total risperidone (λz)
Time frame: Day 0 through Day 85
Terminal half-life of risperidone and total risperidone (T1/2)
Time frame: Day 0 through Day 85
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 11 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 and risperidone 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 11 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 Events [Safety and Tolerability] after a subcutaneous injection of a single 60 mg, 90 mg, and 120 mg dose of risperidone in RBP-7000 in subjects with clinically stable schizophrenia (time frame: Day 1 through Day 85). 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 11 May 2016.