Bipolar I DisorderPhase 1NCT04987658
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
A Phase 1 study testing OLZ/SAM in people with Bipolar I Disorder, run by Alkermes, Inc. at 2 sites in United States.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- OLZ/SAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2021to 11 Aug 2023
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
- Male and female subjects between 10 and 12 years of age, inclusive.
- Subject weighs ≥70 pounds.
- Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.
- Subjects must be considered stable, per investigator judgement.
- Subject is willing to abide by the contraception requirements for the duration of the study.
Who cannot join
- Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study.
- Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1).
- Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%).
- Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening.
- Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening.
- Subject has taken opioid agonists within the 14 days prior to Screening, or has taken long-acting opioid agonist within the 30 days prior to Screening, or has anticipated a need to take opioid medication during the study period (eg, planned surgery, including oral surgery), or has taken opioid antagonists including naltrexone (any formulation) and naloxone within 60 days prior to Screening.
Show all 11Show fewer
- Subject is unable to swallow oral medications, as assessed by the Investigator.
- Subject has a positive urine drug screen for opioids (assessed at Screening and at Visit 2, Day 1).
- Subject has a positive cotinine test (assessed at Screening and at Visit 2, Day 1).
- Subject has an intellectual disability, as assessed by the Investigator.
- Subject has a history of intolerance or hypersensitivity to olanzapine or opioid antagonists, or any component of the study drug.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alkermes Clinical Investigative Site
Cincinnati, Ohio, 45219
Alkermes Investigational Site
Decatur, Georgia, 30030
About this study
Official title: A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM
- Conditions
- Bipolar I Disorder
- Being tested
- OLZ/SAM
- Keywords
- Bipolar I Disorder, Olanzapine, Samidorphan, OLZ/SAM, ALKS 3831, Pediatric pharmacokentics, LYBALVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLZ/SAMDrug
Also called ALKS 3831
Olanzapine and Samidorphan taken once daily over a max period of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Olanzapine/ 5 mg Samidorphan | Experimental | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg) Receives: Drug: OLZ/SAM |
| Group 2 Olanzapine/ 10mg Samidorphan | Experimental | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg) Receives: Drug: OLZ/SAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration observed
Measured: Up to 3 weeks
Area under the plasma concentration-time curve over the 24-hour dosing interval
Measured: Up to 3 weeks
Time to reach maximum concentration
Measured: Up to 3 weeks
Incidence of Adverse Events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start22 Jul 2021
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT04987658
- Sponsor's protocol ID
- ALKS 3831-A311
- Status last verified
- Nov 2023
- First submitted
- 26 Jul 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT04987658
- Acronym / sponsor ID
- ALKS 3831-A311
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Olanzapine, Samidorphan, OLZ/SAM, ALKS 3831, Pediatric pharmacokentics, LYBALVI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 3 Aug 2021 (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.
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Olanzapine/ 5 mg Samidorphan | Experimental | Drug: OLZ/SAMOlanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg) |
| Group 2 Olanzapine/ 10mg Samidorphan | Experimental | Drug: OLZ/SAMOlanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg) |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
- Male and female subjects between 10 and 12 years of age, inclusive.
- Subject weighs ≥70 pounds.
- Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.
- Subjects must be considered stable, per investigator judgement.
Key exclusion criteria (11 listed)
- Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study.
- Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1).
- Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%).
- Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening.
- Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening.
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 |
|---|---|---|
| OLZ/SAMAlso: ALKS 3831Olanzapine and Samidorphan taken once daily over a max period of 21 days | Drug | Group 1 Olanzapine/ 5 mg Samidorphan, Group 2 Olanzapine/ 10mg Samidorphan |
Primary outcome
Maximum plasma concentration observed
Time frame: Up to 3 weeks
Area under the plasma concentration-time curve over the 24-hour dosing interval
Time frame: Up to 3 weeks
Time to reach maximum concentration
Time frame: Up to 3 weeks
Incidence of Adverse Events
Time frame: Up to 6 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 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Bipolar I Disorder
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
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.
2 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 OLZ/SAM in people with Bipolar I Disorder, run by Alkermes, Inc. at 2 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 6 inclusion and 11 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 observed (time frame: Up to 3 weeks). The study lists 4 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 22 Nov 2023.