SchizophreniaPhase 1NCT03150771
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
A Phase 1 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 sites in United States.
Trial summary
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2017to 2 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female individuals between 18 and 64 years, inclusive, at screening with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders: edition 5 (DSM-5)
- Body mass index (BMI) between 18 and 35 kg/m^2 at screening
- Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to screening or male/female subjects who agree to remain abstinent or practice 2 of the approved birth control methods from screening for at least 150 days after dose of Investigational Medical Product (IMP) for female subjects or 180 days after dose of IMP for male subjects.
- Documented history of previously tolerating Aripiprazole per investigator's judgment.
Who cannot join
- Met DSM-5 criteria for substance use disorder within past 180 days
- Positive drug screen for drugs of abuse
- Use of more than 1 antipsychotic medication at screening or baseline, except for oral Aripiprazole administered during tolerability testing and current antipsychotic medication
- Subjects may not receive varenicline beyond the screening visit.
- Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to administration of IMP
- Major surgery within 30 days prior to administration of IMP or surgery during the trial
Show all 13Show fewer
- Subjects at significant risk of committing suicide based on history, psychiatric exams
- Subjects currently in an acute relapse of schizophrenia
- Subjects with a current DSM-5 diagnosis other than schizophrenia
- Subjects with a history of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia
- Subjects who have had electroconvulsive therapy within 2 months prior to administration of IMP
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
- History of or current hepatitis or Acquired Immunodeficiency Syndrome or carriers of Hepatitis B surface antigen (HBsAG), Hepatitis C antigen (anti-HCV) and/or Human Immunodeficiency Virus (HIV) antibodies
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Community Clinical Research Inc.
Austin, Texas, 78754
Woodland International Research Group
Little Rock, Arkansas, 72211
CNRI-San Diego
San Diego, California, 92102
About this study
Official title: A Phase 1, Open-label, Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Aripiprazole 2 Month Intramuscular Depot Administered Gluteally in Adult Subjects With Schizophrenia
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify Maintena
Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Aripiprazole; single; gluteal Receives: Drug: Aripiprazole |
| Cohort 2 | Experimental | Aripiprazole; single; gluteal Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) [safety and tolerability]
AEs will be monitored to assess safety and tolerability of drug
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Clinical Laboratory Tests [safety and tolerability]
Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Electrocardiograms (ECGs) [Safety and tolerability]
Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Vital Signs [safety and tolerability]
Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Extrapyramidal Symptoms (EPS) Rating Scales
EPS score will be monitored to assess safety and tolerability of drug
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Investigator's Assessment of Injection Site
The injection site will be monitored to assess the safety and tolerability of drug
Measured: Screening Days -30 to Day 182 post dose/Early Termination
Visual Analog Scale (VAS) Scores for Pain Perception
VAS score will be monitored to assess safety and tolerability of drug
Measured: Day 1 to Day 28 post dose
Secondary outcomes (5)
Pharmacokinetics - Maximum plasma concentration (Cmax)
The maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole
Measured: Day 1 to Day 182/Early Termination
Pharmacokinetics - time of maximum plasma concentration (tmax)
The amount of time that the maximum plasma concentration of drug at injection site will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole
Measured: Day 1 to Day 182/Early Termination
Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)
AUCt will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine average concentration of drug over time
Measured: Day 1 to Day 182/Early Termination
Pharmacokinetics - AUC calculated from time to infinity
AUCinfinity will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine total drug exposure over time
Measured: Day 1 to Day 182/Early Termination
Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)
t1/2,z will be assessed for plasma Aripiprazole and its major metabolite dehydro-aripiprazole to determine drug persistence in the body
Measured: Day 1 to Day 182/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start14 Jun 2017
- Primary completion18 Apr 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150771
- Sponsor's protocol ID
- 031-201-00104
- Status last verified
- Jun 2018
- First submitted
- 2 May 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Aripiprazole 2 Month Intramuscular Depot Administered Gluteally in Adult Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT03150771
- Acronym / sponsor ID
- 031-201-00104
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AripiprazoleAripiprazole; single; gluteal |
| Cohort 2 | Experimental | Drug: AripiprazoleAripiprazole; single; gluteal |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female individuals between 18 and 64 years, inclusive, at screening with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders: edition 5 (DSM-5)
- Body mass index (BMI) between 18 and 35 kg/m^2 at screening
- Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to screening or male/female subjects who agree to remain abstinent or practice 2 of the approved birth control methods from screening for at least 150 days after dose of Investigational Medical Product (IMP) for female subjects or 180 days after dose of IMP for male subjects.
- Documented history of previously tolerating Aripiprazole per investigator's judgment.
Key exclusion criteria (13 listed)
- Met DSM-5 criteria for substance use disorder within past 180 days
- Positive drug screen for drugs of abuse
- Use of more than 1 antipsychotic medication at screening or baseline, except for oral Aripiprazole administered during tolerability testing and current antipsychotic medication
- Subjects may not receive varenicline beyond the screening visit.
- Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to administration of IMP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: Abilify MaintenaInjection | Drug | Cohort 1, Cohort 2 |
Primary outcome
Incidence of Adverse Events (AEs) [safety and tolerability]
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
AEs will be monitored to assess safety and tolerability of drug
Clinical Laboratory Tests [safety and tolerability]
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.
Electrocardiograms (ECGs) [Safety and tolerability]
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.
Vital Signs [safety and tolerability]
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.
Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug
Extrapyramidal Symptoms (EPS) Rating Scales
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
EPS score will be monitored to assess safety and tolerability of drug
Investigator's Assessment of Injection Site
Time frame: Screening Days -30 to Day 182 post dose/Early Termination
The injection site will be monitored to assess the safety and tolerability of drug
Visual Analog Scale (VAS) Scores for Pain Perception
Time frame: Day 1 to Day 28 post dose
VAS score will be monitored to assess safety and tolerability of drug
5 secondary outcomes
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - time of maximum plasma concentration (tmax)
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - AUC calculated from time to infinity
Time frame: Day 1 to Day 182/Early Termination
Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)
Time frame: Day 1 to Day 182/Early Termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) [safety and tolerability] (time frame: Screening Days -30 to Day 182 post dose/Early Termination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.