SchizophreniaPhase 1NCT02687984
PK, Safety, and Tolerability Study of RBP-7000 of Different Molecular Weight Polymer in Subjects With Schizophrenia
A Phase 1 study testing RBP-7000 in people with Schizophrenia, run by Indivior Inc. at 2 sites in United States.
Trial summary
Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2 different molecular weights (MW) (low and high MW as test treatments) of poly (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to intermediate MW PLGH polymer following single subcutaneous (SC)… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to May 2016
- 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
- Diagnosis of schizophrenia as defined by DSM-5 criteria.
- Clinically stable schizophrenia, as evidenced by the investigator evaluation, outpatient status for at least 30 days prior to screening, and confirmation of stability by a caregiver who has regular supportive contact with the subject.
- Otherwise healthy on the basis of physical examination.
- Body mass index (BMI) between 18 and 35 kg/m^2 and weight of at least 49.9 kg at screening.
Who cannot join
- Subjects taking any oral risperidone product (except the test doses of 0.25 mg of risperidone); or subjects taking any risperidone or 9-hydroxyrisperidone sustained-release or depot formulation within 120 days prior to study screening; or subjects who have received the 3-month depot formulation of 9-hydroxyrisperidone within 2 years of study screening.
- Subjects taking a clinically relevant inducer or inhibitor of cytochrome P450 (CYP) 2D6, or CYP3A4, who have not undergone proper washout (minimum of 5 half-lives of the medication) of this prohibited medication prior to Day 1.
- Medications, which in the opinion of the Investigator in conjunction with the medical monitor, may be expected to significantly interfere with metabolism or excretion of risperidone and/or 9-hydroxyrisperidone; may be associated with a significant drug interaction with risperidone; or may pose a significant risk to a subject's participation in the study.
- Any natural products or herbal preparations including all vitamins and supplements throughout the study.
- Subjects with a history of cancer unless disease-free for ≥5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin).
- Subjects with any other active medical condition/disorder/disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug.
Show all 25Show fewer
- Subjects that had an exacerbation of schizophrenia in the last 30 days.
- Subjects with evidence or history (in the past 6 months prior to screening) of a significant hepatic disorder that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug, including:
- Acute or chronic hepatitis, including but not limited to hepatitis B or C.
- Total bilirubin >1.5 x the upper limit of normal (ULN), or
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x ULN.
- Subjects with a history of severe renal disease, or creatinine clearance <60 mL/min
- Subjects with evidence or history of orthostatic hypotension within 6 months of screening.
- Subjects with absolute neutrophil count <1.5x 10^9/L (African and African/American <1.2x 10^9/L).
- Subjects with a history of drug-induced leucopenia.
- Subjects who have acquired immune deficiency syndrome (AIDS) or to be human immunodeficiency virus (HIV)-positive.
- Subjects with other medical conditions including, but not limited to, history of heart attack (myocardial infarction) or brain injury (traumatic injury with loss of consciousness and/or cerebrovascular accident), or clinically significant low blood pressure or arrhythmias as interpreted by the Principal Investigator or medically qualified sub-investigator.
- Subjects with congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening, or a corrected QT interval (Fridericia - QTcF) >450 msec (male) or >470 msec (female) at screening (Visit 1).
- Subjects with suicidal ideation with intent or plan
- Subjects with uncontrolled depression, in the opinion of the Investigator.
- Subjects with a diagnosis of insulin-dependent diabetes, or who have a hemoglobin A1c (HbA1c) ≥8.0% at screening, or have had changes in diabetic medication regimen in the 28 days prior to signing the informed consent document.
- Subjects with prior allergic reactions, sensitivities or other known contraindications to any component of RBP-7000 (e.g., risperidone, PLGH or NMP).
- Women of childbearing potential who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
- Subjects with the presence of opioids, cocaine, amphetamines, methadone, barbiturates, benzodiazepines, methamphetamines, cannabinoids, or phencyclidine in the urine as assessed by a urine drug screen.
- Subjects with epilepsy or other seizure disorders, Parkinson's disease or dementia.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Collaborative Neuroscience Network
Torrance, California, 90502
About this study
Official title: A Multicenter, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of RBP-7000 Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) Compared to Intermediate Molecular Weight (Reference Treatment) Polymer in Subjects With Schizophrenia
Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2 different molecular weights (MW) (low and high MW as test treatments) of poly (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in subjects with stable schizophrenia.
Secondary Objective:
To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW polymer in subjects with stable schizophrenia.
Read the detailed description
This is a multicenter, randomized, open-label, single-dose, parallel-group study in subjects with clinically stable schizophrenia who are not currently taking risperidone. A total of approximately 48 subjects (16 per group) will be randomized to receive a single subcutaneous (SC) injection of RBP-7000 120 mg formulated with PLGH polymer of either 21 kilodaltons (kDa) (low MW group), 29 kDa of PLGH polymer (high MW group), or 26 kDa of PLGH polymer (intermediate MW group).
- Conditions
- Schizophrenia
- Being tested
- RBP-7000
- Keywords
- Schizophrenia, Long-acting Risperidone, Atrigel
- 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
Also called Risperdal
A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer.
| Study group | Role | What they receive |
|---|---|---|
| RBP-7000 PLGH A | Experimental | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 21 kDa PLGH polymer. Receives: Drug: RBP-7000 |
| RBP-7000 PLGH B | Experimental | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 29 kDa PLGH polymer. Receives: Drug: RBP-7000 |
| RBP-7000 PLGH C | Active comparator | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 26 kDa PLGH polymer. This intermediate molecular weight treatment serves as the reference treatment. Receives: Drug: RBP-7000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Burst Parameters: Cmax of risperidone
Maximum observed plasma concentration
Measured: approximately 0-24 hours; Day 1 to Day 2
Initial Burst Parameters: AUC0-24h of risperidone
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose; calculated using the linear trapezoidal rule.
Measured: approximately 0-24 hours; Day 1 to Day 2
Secondary Peak Parameters: Cmax of risperidone
Maximum observed plasma concentration
Measured: approximately 24-672 hours; Day 2 to Day 29
Secondary Peak Parameters: AUCD2-D29 of risperidone
Area under the plasma concentration-time curve from 24 hours post-dose (Day 2) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
Measured: approximately 24-672 hours; Day 2 to Day 29
Overall Parameters: Cmax of risperidone
Maximum observed plasma concentration
Measured: Day 1 to Day 29
Overall Parameters: AUCD1-D29 of risperidone
Area under the plasma concentration-time curve from time 0 (Day 1) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
Measured: Day 1 to Day 29
Secondary outcomes (7)
Initial Burst Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Measured: approximately 0-24 hours; Day 1 to Day 2
Initial Burst Parameters: AUC0-24h of 9-hydroxyrisperidone
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose; calculated using the linear trapezoidal rule.
Measured: approximately 0-24 hours; Day 1 to Day 2
Secondary Peak Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Measured: approximately 24-672 hours; Day 2 to Day 29
Secondary Peak Parameters: AUCD2-D29 of 9-hydroxyrisperidone
Area under the plasma concentration-time curve from 24 hours post-dose (Day 2) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
Measured: approximately 24-672 hours; Day 2 to Day 29
Overall Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Measured: Day 1 to Day 29
Overall Parameters: AUCD1-D29 of 9-hydroxyrisperidone
Area under the plasma concentration-time curve from time 0 (Day 1) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
Measured: Day 1 to Day 29
Summary of Participants with Adverse Events
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687984
- Sponsor's protocol ID
- RB-US-15-0001
- Status last verified
- Jan 2017
- First submitted
- 17 Feb 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of RBP-7000 Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) Compared to Intermediate Molecular Weight (Reference Treatment) Polymer in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT02687984
- Acronym / sponsor ID
- RB-US-15-0001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Long-acting Risperidone, Atrigel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Feb 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.
Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2 different molecular weights (MW) (low and high MW as test treatments) of poly (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in subjects with stable schizophrenia.
Secondary Objective:
To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW polymer in subjects with stable schizophrenia.
Detailed description
This is a multicenter, randomized, open-label, single-dose, parallel-group study in subjects with clinically stable schizophrenia who are not currently taking risperidone. A total of approximately 48 subjects (16 per group) will be randomized to receive a single subcutaneous (SC) injection of RBP-7000 120 mg formulated with PLGH polymer of either 21 kilodaltons (kDa) (low MW group), 29 kDa of PLGH polymer (high MW group), or 26 kDa of PLGH polymer (intermediate MW group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBP-7000 PLGH A | Experimental | Drug: RBP-7000A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 21 kDa PLGH polymer. |
| RBP-7000 PLGH B | Experimental | Drug: RBP-7000A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 29 kDa PLGH polymer. |
| RBP-7000 PLGH C | Active comparator | Drug: RBP-7000A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 26 kDa PLGH polymer. This intermediate molecular weight treatment serves as the reference treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia as defined by DSM-5 criteria.
- Clinically stable schizophrenia, as evidenced by the investigator evaluation, outpatient status for at least 30 days prior to screening, and confirmation of stability by a caregiver who has regular supportive contact with the subject.
- Otherwise healthy on the basis of physical examination.
- Body mass index (BMI) between 18 and 35 kg/m^2 and weight of at least 49.9 kg at screening.
Key exclusion criteria (25 listed)
- Subjects taking any oral risperidone product (except the test doses of 0.25 mg of risperidone); or subjects taking any risperidone or 9-hydroxyrisperidone sustained-release or depot formulation within 120 days prior to study screening; or subjects who have received the 3-month depot formulation of 9-hydroxyrisperidone within 2 years of study screening.
- Subjects taking a clinically relevant inducer or inhibitor of cytochrome P450 (CYP) 2D6, or CYP3A4, who have not undergone proper washout (minimum of 5 half-lives of the medication) of this prohibited medication prior to Day 1.
- Medications, which in the opinion of the Investigator in conjunction with the medical monitor, may be expected to significantly interfere with metabolism or excretion of risperidone and/or 9-hydroxyrisperidone; may be associated with a significant drug interaction with risperidone; or may pose a significant risk to a subject's participation in the study.
- Any natural products or herbal preparations including all vitamins and supplements throughout the study.
- Subjects with a history of cancer unless disease-free for ≥5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin).
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-7000Also: RisperdalA single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer. | Drug | RBP-7000 PLGH A, RBP-7000 PLGH B, RBP-7000 PLGH C |
Primary outcome
Initial Burst Parameters: Cmax of risperidone
Time frame: approximately 0-24 hours; Day 1 to Day 2
Maximum observed plasma concentration
Initial Burst Parameters: AUC0-24h of risperidone
Time frame: approximately 0-24 hours; Day 1 to Day 2
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose; calculated using the linear trapezoidal rule.
Secondary Peak Parameters: Cmax of risperidone
Time frame: approximately 24-672 hours; Day 2 to Day 29
Maximum observed plasma concentration
Secondary Peak Parameters: AUCD2-D29 of risperidone
Time frame: approximately 24-672 hours; Day 2 to Day 29
Area under the plasma concentration-time curve from 24 hours post-dose (Day 2) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
Overall Parameters: Cmax of risperidone
Time frame: Day 1 to Day 29
Maximum observed plasma concentration
Overall Parameters: AUCD1-D29 of risperidone
Time frame: Day 1 to Day 29
Area under the plasma concentration-time curve from time 0 (Day 1) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule.
7 secondary outcomes
Initial Burst Parameters: Cmax of 9-hydroxyrisperidone
Time frame: approximately 0-24 hours; Day 1 to Day 2
Initial Burst Parameters: AUC0-24h of 9-hydroxyrisperidone
Time frame: approximately 0-24 hours; Day 1 to Day 2
Secondary Peak Parameters: Cmax of 9-hydroxyrisperidone
Time frame: approximately 24-672 hours; Day 2 to Day 29
Secondary Peak Parameters: AUCD2-D29 of 9-hydroxyrisperidone
Time frame: approximately 24-672 hours; Day 2 to Day 29
Overall Parameters: Cmax of 9-hydroxyrisperidone
Time frame: Day 1 to Day 29
Overall Parameters: AUCD1-D29 of 9-hydroxyrisperidone
Time frame: Day 1 to Day 29
Summary of Participants with Adverse Events
Time frame: Day 1 to Day 29
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 31 Jan 2017.
- 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.
Study Director study director
Indivior Inc.
2 sites 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 2 sites 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 25 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Initial Burst Parameters: Cmax of risperidone (time frame: approximately 0-24 hours; Day 1 to Day 2). The study lists 6 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 31 Jan 2017.