SchizophreniaPhase 1NCT02320032
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
A Phase 1 study testing Aripiprazole Lauroxil in people with Schizophrenia, run by Alkermes, Inc. at 16 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- 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
- 140 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2014to Apr 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 stable 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 35.0 kg/m2, inclusive
- Additional criteria may apply
Who cannot join
- Is pregnant, breastfeeding, or is planning to become pregnant during the study period
- Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
- 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
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Lauderhill, Florida, 33161
Alkermes Investigational Site
Leesburg, Florida, 34748
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Maitland, Florida, 32751
Alkermes Investigational Site
Marlton, New Jersey, 8053
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
Tampa, Florida, 33613
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole Lauroxil
- Keywords
- Alkermes, Schizophrenia, Aripiprazole, Aripiprazole lauroxil, ALKS 9072
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole LauroxilDrug
Gluteal IM injection, given once every 4 to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Lauroxil - A | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence A Receives: Drug: Aripiprazole Lauroxil |
| Aripiprazole Lauroxil - B | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence B Receives: Drug: Aripiprazole Lauroxil |
| Aripiprazole Lauroxil - C | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence C Receives: Drug: Aripiprazole Lauroxil |
| Aripiprazole Lauroxil - D | Experimental | Intramuscular (IM) injection Dose and Dosing Sequence D Receives: Drug: Aripiprazole Lauroxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-last
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Measured: Up to 45 weeks
C max
Maximum plasma concentration
Measured: Up to 45 weeks
T max
Time to maximum plasma concentration
Measured: Up to 45 weeks
Secondary outcomes (2)
AUC 0-tau
Area under the plasma-concentration time curve over the dose interval
Measured: Up to 45 weeks
Safety and tolerability will be measured by incidence of adverse events
Measured: Up to 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320032
- Sponsor's protocol ID
- ALK9072-A105
- Status last verified
- Aug 2018
- First submitted
- 16 Dec 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
PubMed 28350572Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.
PubMed 32621071Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.
PubMed 28597226
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
- ClinicalTrials.gov ID
- NCT02320032
- Acronym / sponsor ID
- ALK9072-A105
- Conditions
- Schizophrenia
- Keywords
- Alkermes, Schizophrenia, Aripiprazole, Aripiprazole lauroxil, ALKS 9072
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Dec 2014 (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.
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole Lauroxil - A | Experimental | Drug: Aripiprazole LauroxilIntramuscular (IM) injection Dose and Dosing Sequence A |
| Aripiprazole Lauroxil - B | Experimental | Drug: Aripiprazole LauroxilIntramuscular (IM) injection Dose and Dosing Sequence B |
| Aripiprazole Lauroxil - C | Experimental | Drug: Aripiprazole LauroxilIntramuscular (IM) injection Dose and Dosing Sequence C |
| Aripiprazole Lauroxil - D | Experimental | Drug: Aripiprazole LauroxilIntramuscular (IM) injection Dose and Dosing Sequence D |
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 stable 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 35.0 kg/m2, inclusive
- Additional criteria may apply
Key exclusion criteria (6 listed)
- Is pregnant, breastfeeding, or is planning to become pregnant during the study period
- Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
- 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 LauroxilGluteal IM injection, given once every 4 to 8 weeks | Drug | Aripiprazole Lauroxil - A, Aripiprazole Lauroxil - B, Aripiprazole Lauroxil - C, Aripiprazole Lauroxil - D |
Primary outcome
AUC 0-last
Time frame: Up to 45 weeks
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
C max
Time frame: Up to 45 weeks
Maximum plasma concentration
T max
Time frame: Up to 45 weeks
Time to maximum plasma concentration
2 secondary outcomes
AUC 0-tau
Time frame: Up to 45 weeks
Safety and tolerability will be measured by incidence of adverse events
Time frame: Up to 45 weeks
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 29 Aug 2018.
- Results publication: PubMed 28350572Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
- Derived from this study: PubMed 32621071Weiden PJ, Du Y, von Moltke L, Wehr A, Hard M, Marandi M, Walling DP. Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. CNS Drugs. 2020 Sep;34(9):961-972. doi: 10.1007/s40263-020-00745-1.
- Derived from this study: PubMed 28597226Hard ML, Mills RJ, Sadler BM, Wehr AY, Weiden PJ, von Moltke L. Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model. CNS Drugs. 2017 Jul;31(7):617-624. doi: 10.1007/s40263-017-0447-7.
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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.
Alkermes Medical Director, MD study director
Alkermes, Inc.
16 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, run by Alkermes, Inc. at 16 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
AUC 0-last (time frame: Up to 45 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320032, which also lists 3 linked publications.
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 29 Aug 2018.