SchizophreniaPhase 1NCT02636842
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
A Phase 1 study testing Aripiprazole Lauroxil in people with Schizophrenia and Schizoaffective Disorder, run by Alkermes, Inc. at 6 sites in United States.
Trial summary
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Aripiprazole Lauroxil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2015to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of chronic schizophrenia or schizoaffective disorder
- Has demonstrated ability to tolerate aripiprazole
- Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
- Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
- Additional criteria may apply
Who cannot join
- Is pregnant, is planning to become pregnant, or is currently breastfeeding
- Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
- Is a danger to himself/herself at screening or upon admission
- Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Has a positive urine drug screen at screening or Day 1
- Additional criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigative Site
Dallas, Texas, 75243
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Lemon Grove, California, 91945
Alkermes Investigational Site
Marlton, New Jersey, 80530
Alkermes Investigational Site
Oakland, California, 94612
About this study
Official title: A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Aripiprazole Lauroxil
- Keywords
- Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole LauroxilDrug
Also called ARISTADA TM
Intramuscular (IM) injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Location | Other | Deltoid or Gluteal Muscle Receives: Drug: Aripiprazole Lauroxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: Up to 7 days
Secondary outcomes (5)
Time to Cmax (Tmax)
Measured: Up to 7 days
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)
Measured: Up to 7 days
Area under the concentration-time curve from time zero to time t (AUC0-t)
Measured: Up to 7 days
Terminal elimination half-life (t½)
Measured: Up to 7 days
Safety will be determined by incidence of adverse events
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Risinger, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636842
- Sponsor's protocol ID
- ALK9072-A106
- Status last verified
- Jul 2016
- First submitted
- 18 Dec 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02636842
- Acronym / sponsor ID
- ALK9072-A106
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Location | Other | Drug: Aripiprazole LauroxilDeltoid or Gluteal Muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of chronic schizophrenia or schizoaffective disorder
- Has demonstrated ability to tolerate aripiprazole
- Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
- Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
- Additional criteria may apply
Key exclusion criteria (6 listed)
- Is pregnant, is planning to become pregnant, or is currently breastfeeding
- Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
- Is a danger to himself/herself at screening or upon admission
- Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Has a positive urine drug screen at screening or Day 1
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 |
|---|---|---|
| Aripiprazole LauroxilAlso: ARISTADA TMIntramuscular (IM) injection, single dose | Drug | Location |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Up to 7 days
5 secondary outcomes
Time to Cmax (Tmax)
Time frame: Up to 7 days
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)
Time frame: Up to 7 days
Area under the concentration-time curve from time zero to time t (AUC0-t)
Time frame: Up to 7 days
Terminal elimination half-life (t½)
Time frame: Up to 7 days
Safety will be determined by incidence of adverse events
Time frame: Up to 7 days
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 14 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Robert Risinger, MD study director
Alkermes, Inc.
6 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 Lauroxil in people with Schizophrenia and Schizoaffective Disorder, run by Alkermes, Inc. at 6 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 5 inclusion and 6 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Maximum plasma concentration (Cmax) (time frame: Up to 7 days). 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 14 Jul 2016.