SchizophreniaPhase 1NCT02804568
A Phase 1 Safety Study in Adults With Schizophrenia
A Phase 1 study testing ALKS 3831 in people with Schizophrenia, run by Alkermes, Inc. at 3 sites in United States.
Trial summary
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ALKS 3831
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Aug 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has a body mass index (BMI) of 18.0-35.0 kg/m^2, inclusive
- Has a primary diagnosis of schizophrenia
- Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
- Appropriate for outpatient treatment
- Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
- Willing and able to provide government-issued identification
Show all 9Show fewer
- Is in good physical health
- Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
- Additional criteria may apply
Who cannot join
- Is currently pregnant or breastfeeding
- Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
- Poses a current suicide risk at Visits 1 or 2
- Has a history of poor or inadequate response to treatment with olanzapine
- Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
- Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
Show all 12Show fewer
- Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
- Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
- Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
- Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
- Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
- Additional criteria may apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alkermes Investigational Site
Clementon, New Jersey, 08021
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Little Rock, Arkansas, 72205
About this study
Official title: A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
- Conditions
- Schizophrenia
- Being tested
- ALKS 3831
- Keywords
- Schizophrenia, Alkermes, ALK 3831, Samidorphan
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 3831Drug
Oral capsule, daily administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Olanzapine/samidorphan 10 mg/10 mg Receives: Drug: ALKS 3831 |
| Group 2 | Experimental | Olanzapine/samidorphan 20 mg/10 mg Receives: Drug: ALKS 3831 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: Up to 15 days of dosing
Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)
Measured: Up to 15 days of dosing
Secondary outcomes (1)
Safety will be determined by incidence of drug-related adverse events
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David McDonnell, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804568
- Sponsor's protocol ID
- ALK3831-A104
- Status last verified
- Sep 2016
- First submitted
- 15 Jun 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.
PubMed 30348514
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT02804568
- Acronym / sponsor ID
- ALK3831-A104
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Alkermes, ALK 3831, Samidorphan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ALKS 3831Olanzapine/samidorphan 10 mg/10 mg |
| Group 2 | Experimental | Drug: ALKS 3831Olanzapine/samidorphan 20 mg/10 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Has a body mass index (BMI) of 18.0-35.0 kg/m^2, inclusive
- Has a primary diagnosis of schizophrenia
- Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
- Appropriate for outpatient treatment
- Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
Key exclusion criteria (12 listed)
- Is currently pregnant or breastfeeding
- Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
- Poses a current suicide risk at Visits 1 or 2
- Has a history of poor or inadequate response to treatment with olanzapine
- Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
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 |
|---|---|---|
| ALKS 3831Oral capsule, daily administration | Drug | Group 1, Group 2 |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Up to 15 days of dosing
Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)
Time frame: Up to 15 days of dosing
1 secondary outcome
Safety will be determined by incidence of drug-related adverse events
Time frame: Up to 21 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 22 Sep 2016.
- Derived from this study: PubMed 30348514Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
David McDonnell, MD study director
Alkermes, Inc.
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 ALKS 3831 in people with Schizophrenia, run by Alkermes, 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 9 inclusion and 12 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 22 Sep 2016. 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?
Maximum plasma concentration (Cmax) (time frame: Up to 15 days of dosing). The study lists 2 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 NCT02804568, which also lists 1 linked publication.
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 22 Sep 2016.