Multiple Ascending Dose Study of the Safety, Tolerability... | NCT01677377 | Trialant
NCT01677377
Sponsor
Indivior Inc.
Status
Completed
Last Update Posted
Oct 23, 2018Actual
Enrollment
45Actual
Phase
Phase 2
Conditions
Schizophrenia
Interventions
Risperidone
RBP-7000
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01677377
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RB-US-09-0009
Secondary IDs
Not provided
Brief Title
Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy
Official Title
A Phase 2A, Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Primary Pharmacodynamic Markers of Efficacy of 60mg, 90mg, and 120mg of Risperidone in RBP-7000 Subcutaneous Injections in Subjects With Clinically Stable Schizophrenia
Acronym
Not provided
Organization
Indivior Inc.INDUSTRY
Status Module
Record Verification Date
Oct 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2012
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
First Submitted Date
Aug 27, 2012
First Submission Date that Met QC Criteria
Aug 29, 2012
First Posted Date
Sep 3, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 31, 2018
Results First Submitted that Met QC Criteria
Oct 22, 2018
Results First Posted Date
Oct 23, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 7, 2015
Certification/Extension First Submitted that Passed QC Review
Aug 7, 2015
Certification/Extension First Posted Date
Aug 24, 2015Estimated
Last Update Submitted Date
Oct 22, 2018
Last Update Posted Date
Oct 23, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Indivior Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages of risperidone with clinically stable schizophrenia
Detailed Description
This will be an open-label, Phase 2A, multiple ascending dose study in 1 to 3 sites, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple subcutaneous injections of 60mg, 90mg, and 120mg doses of risperidone in the RBP-7000 formulation, in subjects with clinically-stable schizophrenia who are on a once daily stable dose of 2mg, 3mg, or 4mg of oral risperidone.
Conditions Module
Conditions
Schizophrenia
Keywords
Schizophrenia
Schizophrenic
Schizophrenias
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
45Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1, RBP-7000 60 mg
Experimental
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
Drug: Risperidone
Drug: RBP-7000
Cohort 2, RBP-7000 90 mg
Experimental
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
Drug: Risperidone
Drug: RBP-7000
Cohort 3, RBP-7000 120 mg
Experimental
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Drug: Risperidone
Drug: RBP-7000
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Risperidone
Drug
Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.
Day 1 to Day 106
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Secondary Outcomes
Measure
Description
Time Frame
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female
> 18 to < 65 years
Diagnosis of paranoid, residual, or undifferentiated schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria
Status: clinically stable subjects defined as subjects with no hospitalizations for acute exacerbations within 3 months of screening and screening total Positive and Negative Syndrome Scale (PANSS) score < 60
Subjects who have given written informed consent
Exclusion Criteria:
Subjects taking any risperidone sustained release formulation within the 60 days prior to study screening
Subjects taking the following concurrent medication/over-the-counter products:
Inducers or inhibitors of cytochrome P450 2D6 (CYP-2D6) within 14 days or 7 half - lives (whichever occurs last) prior to study screening
Bupropion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine within 30 days prior to study screening
Clozapine, phenothiazines, aripiprazole, haloperidol, or any other antipsychotic other than oral risperidone within 14 days prior to study screening
Selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) or serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine, desvenlafaxine, duloxetine) within 30 days prior to study screening
Opioids or opioid-containing analgesics within 14 days prior to study screening
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 that may pose a significant risk to subjects' participation in the study
Subjects with a history of cancer (with the exception of 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 and/or outcome evaluation of the study drug
Subjects with evidence or history of a significant hepatic disorder that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. Individuals with acute hepatitis (including but not limited to B or C); or individuals with 1) total bilirubin >1.5x the upper limit of normal and/or 2) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) will be excluded
Subjects with hepatitis C antibody and AST, ALT, or alkaline phosphatase >2x and total bilirubin >1.3 mg/dL will be excluded
Subjects with a history of renal disease, or a creatinine clearance of less than 80 mL/min (as determined by the Cockcroft Gault formula)
Subjects with an international normalized ratio >2.0 at screening
Subjects with corrected QT interval (Bazett's - QTcB) >450 msec (male) or >470 msec (female) at screening. Subjects with a QTc above these levels due to a benign right bundle branch block can be included in the study at the discretion of the PI
Subjects who are known to have AIDS or to be HIV positive
Subjects with suicidal ideation with intent and plan (Columbia-Suicide Severity Rating Scale (C-SSRS) affirmative answers to questions 4 and 5 of the ideation section) or suicide attempts within the last six months as noted on the C-SSRS, or subjects with uncontrolled depression in the opinion of the investigator
Subjects with known diagnosis of type 1 or 2 diabetes or subjects with Hemoglobin A1c >7.0 at screening
Subjects who have participated in a clinical trial within 30 days prior to study screening
Subjects who meet the DSM-IV-TR criteria for alcohol abuse or dependence within the last six months of screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Philippa Whitelaw, Sr. Dir of Proj Deliver
Pharmaceutical Research Associates
Study Director
Ashley Huston, PMP
Pharmaceutical Research Associates
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Woodland International Research Group, Inc.
Little Rock
Alaska
72211
United States
Ocean View Psychiatric Health Facility
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
This was an open-label, Phase 2A, multiple-ascending dose study performed at 2 sites in the U.S. Seventy subjects were screened and 45 subjects were enrolled and received RBP-7000.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
FG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
FG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG00215 subjects
COMPLETED
FG00014 subjects
FG00114 subjects
FG0029 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0026 subjects
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
Lost to Follow-up
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
Safety
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.
Safety population
Posted
Count of Participants
Participants
Day 1 to Day 106
ID
Title
Description
Adverse Events Module
Frequency Threshold
0
Time Frame
Day 1 to Day 106
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Psychotic disorder
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Otorrhoea
Ear and labyrinth disorders
MedDRA (15.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Global Director, Clinical Development
Indivior, Inc.
804-379-1090
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D012559
Schizophrenia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D018967
Risperidone
Ancestor Terms
ID
Term
D011744
Pyrimidinones
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort 1, RBP-7000 60 mg
Cohort 2, RBP-7000 90 mg
Cohort 3, RBP-7000 120 mg
Risperdal
RBP-7000
Drug
RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.
Cohort 1, RBP-7000 60 mg
Cohort 2, RBP-7000 90 mg
Cohort 3, RBP-7000 120 mg
risperidone in Atrigel
Day 1-2, Day 57-58
Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Percent Fluctuation Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Swing Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.
Day 2-29, Day 58-85
Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Total Risperidone PK: Percent Fluctuation Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Total Risperidone PK: Swing Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Percent Fluctuation Over the PK Profile
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Swing Over the PK Profile
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Percent Fluctuation Over the Secondary Peak
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Swing Over the Secondary Peak
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-2, Day 57-58
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Swing Over the PK Profile
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 1-28, Day 57-84
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Swing Over the Secondary Peak
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
Day 2-29, Day 58-85
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106
The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106
The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.
This outcome reports the number of participants with suicidal ideation or behavior.
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
Long Beach
California
90806
United States
0 subjects
FG0011 subjects
FG0021 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
BG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
BG003
Total
Total of all reporting groups
15
BG00115
BG00215
BG00345
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.7± 9.98
BG00142.5± 9.93
BG00241.7± 7.96
BG00342.6± 9.16
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0014
BG0021
BG00312
Male
BG0008
BG00111
BG00214
BG00333
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0012
BG0020
BG0033
Not Hispanic or Latino
BG00014
BG00113
BG00215
BG00342
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0007
BG0014
BG0024
BG00315
Black or African American
BG0007
BG00111
BG00210
BG00328
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
Asian
BG0000
BG0010
BG0020
BG0030
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Other
BG0001
BG0010
BG0021
BG0032
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00083.76± 16.279
BG00184.07± 13.707
BG00292.63± 14.075
BG00386.82± 14.980
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000172.19± 8.731
BG001175.50± 11.137
BG002174.41± 8.346
BG003174.03± 9.372
Body Mass Index
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.13± 4.487
BG00127.35± 4.176
BG00230.43± 3.911
BG00328.64± 4.309
Cytochrome P450 2D6 (CYP-2D6)
CYP-2D6 is an enzyme responsible for the metabolism and elimination of many drugs. Considerable variation exists in the efficiency and amount of CYP-2D6 enzyme produced between individuals. Hence, for drugs that are metabolized by CYP-2D6, certain individuals will eliminate these drugs quickly (ultrarapid metabolizers) while others slowly (poor metabolizers).
poor metabolizer - little or no CYP-2D6 function
intermediate metabolizers - metabolize drugs at a rate somewhere between the poor and extensive metabolizers
extensive metabolizer - normal CYP-2D6 function
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Intermediate
BG0003
BG0010
BG0021
BG0034
Poor
BG0001
BG0011
BG0020
BG0032
Extensive
BG00011
BG00114
BG00214
BG00339
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
No TEAEs
Title
Measurements
OG0004
OG0014
OG0027
1 or more TEAEs
Title
Measurements
OG00011
OG00111
OG0028
Related TEAEs
Title
Measurements
OG0006
OG00111
OG0024
Serious TEAEs
Title
Measurements
OG0000
OG0010
OG0021
Serious, related TEAE
Title
Measurements
OG0000
OG0010
OG0020
TEAE causing discontinuation
Title
Measurements
OG0000
OG0010
OG0020
Death
Title
Measurements
OG0000
OG0010
OG0020
Primary
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Percent Fluctuation Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Swing Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00114
OG00210
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.8 to 2.9)
OG0011.6(1.0 to 2.9)
OG0021.2(1.0 to 1.7)
Primary
Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0000.976(0.62 to 2.21)
OG0011.525(0.73 to 2.83)
OG0021.105(0.81 to 2.19)
Primary
Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration.
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Percent Fluctuation Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
Total Risperidone PK: Swing Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Percent Fluctuation Over the PK Profile
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
Risperidone PK: Swing Over the PK Profile
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00114
OG00210
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.6 to 4.8)
OG0011.7(1.0 to 3.2)
OG0021.1(1.0 to 1.9)
Primary
Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0001.049(0.20 to 2.16)
OG0011.214(0.54 to 2.85)
OG0021.155(0.62 to 1.59)
Primary
Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00213
Title
Measurements
Primary
Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00213
Title
Measurements
Primary
Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Percent Fluctuation Over the Secondary Peak
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00213
Title
Measurements
Primary
Risperidone PK: Swing Over the Secondary Peak
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)
AUC0-24 calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak
Cmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak
Tmax determined directly from individual concentration-time data.
Results are reported across two timeframes:
Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)
Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-2, Day 57-58
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Initial Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)
AUCtau calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile
The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Swing Over the PK Profile
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile
Results are reported across two timeframes:
Overall, Injection 1 (Day 1 injection to Day 28)
Overall, Injection 3 (Day 57 injection to Day 84)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Overall, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))
Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00114
OG00210
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.8 to 2.1)
OG0011.5(1.0 to 2.8)
OG0021.2(1.0 to 1.8)
Primary
9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))
Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 1-28, Day 57-84
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00014
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0000.997(0.51 to 2.20)
OG0011.442(0.74 to 2.51)
OG0021.076(0.89 to 2.42)
Primary
9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)
Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hr*ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)
The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)
Maximum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak
Minimum plasma concentrations determined directly from individual concentration-time data.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ng/mL
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak
The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
percentage of average concentration
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
Primary
9-hydroxyrisperidone PK: Swing Over the Secondary Peak
The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
ratio
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Primary
9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak
Results are reported across two timeframes:
Secondary Peak, Injection 1 (Day 2 - Day 29)
Secondary Peak, Injection 3 (Day 58 - Day 85)
The PK sampling schedule was:
Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose
Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration
The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.
Posted
Median
Full Range
hours
Day 2-29, Day 58-85
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Secondary Peak, Injection 1
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:
The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).
Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.
The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale.
Safety
Posted
Median
Full Range
units on a scale
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline: General Psychopathology Scale
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.
Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.
Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline.
Safety
Posted
Median
Full Range
units on a scale
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline: Severity of illness
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.
The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia).
Safety
Posted
Median
Full Range
units on a scale
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106
The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.
Safety
Posted
Median
Full Range
units on a scale
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106
The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.
Safety
Posted
Median
Full Range
units on a scale
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
Secondary
Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106
The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.
This outcome reports the number of participants with suicidal ideation or behavior.
Safety
Posted
Count of Participants
Participants
Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)
ID
Title
Description
OG000
Cohort 1, RBP-7000 60 mg
Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87.
OG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
OG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Baseline: Suicidal ideation or behavior
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00215
Title
Measurements
0
15
0
15
11
15
EG001
Cohort 2, RBP-7000 90 mg
Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87.
0
15
0
15
11
15
EG002
Cohort 3, RBP-7000 120 mg
Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
0
15
1
15
8
15
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0023 affected15 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Toothache
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Constipation
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Dry mouth
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Fatigue
General disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Influenza-like illness
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Nasopharyngitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0021 affected15 at risk
Cellulitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Gastroenteritis viral
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Tooth infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Urethritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Urinary tract infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Weight increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0004 affected15 at risk
EG0015 affected15 at risk
EG0023 affected15 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0020 affected15 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0022 affected15 at risk
Headache
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0003 affected15 at risk
EG0013 affected15 at risk
EG0021 affected15 at risk
Extrapyramidal disorder
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected15 at risk
EG0021 affected15 at risk
Somnolence
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0021 affected15 at risk
Drooling
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Akathisia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Dizziness
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Tremor
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Anxiety
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Depression
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Insomnia
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Pollakiuria
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Pyuria
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Sexual dysfunction
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0023 affected15 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0021 affected15 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Dermititis contact
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
Hot flush
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multicenter publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.