Healthy VolunteersPhase 1NCT02922426
An Insulin Sensitivity Study in Healthy Subjects
A Phase 1 study testing ALKS 3831 and Olanzapine in people with Healthy Volunteers, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALKS 3831 and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 20 Jul 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 18.0 and < 25.0 kg/m^2 at screening and randomization
- No prior history of regular smoking or nicotine use
- Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
- Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
- Additional criteria may apply
Who cannot join
- Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
- Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
- Has a lifetime history of diabetes
- Has a known risk of narrow-angle glaucoma
- Has a clinically significant illness within 30 days prior to screening or admission to the clinic
- Has a history of dependence on any substance other than caffeine
Show all 14Show fewer
- Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
- Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
- Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
- Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
- Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
- Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
- Has prior use of any antipsychotic medication, including on and off label uses
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Alkermes Investigational Site
Chula Vista, California, 91911
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
- Conditions
- Healthy Volunteers
- Being tested
- ALKS 3831, Olanzapine, Placebo
- Keywords
- ALKS 3831, Samidorphan, Olanzapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 3831Drug
Daily dosing for 21 consecutive days
OlanzapineDrug
Daily dosing for 21 consecutive days
PlaceboDrug
Daily dosing for 21 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| ALKS 3831 | Experimental | Oral, bilayer tablet Receives: Drug: ALKS 3831 |
| Olanzapine | Active comparator | Oral, bilayer tablet Receives: Drug: Olanzapine |
| Placebo | Placebo comparator | Oral, bilayer tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose concentrations
Differences will be compared among treatment groups
Measured: 21 days
Secondary outcomes (2)
Changes in insulin concentrations
Differences will be compared among treatment groups
Measured: 21 days
Incidence of treatment-emergent adverse events (AEs)
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT02922426
- Sponsor's protocol ID
- ALK3831-A108
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine
- ClinicalTrials.gov ID
- NCT02922426
- Acronym / sponsor ID
- ALK3831-A108
- Conditions
- Healthy Volunteers
- Keywords
- ALKS 3831, Samidorphan, Olanzapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 4 Oct 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 characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALKS 3831 | Experimental | Drug: ALKS 3831Oral, bilayer tablet |
| Olanzapine | Active comparator | Drug: OlanzapineOral, bilayer tablet |
| Placebo | Placebo comparator | Drug: PlaceboOral, bilayer tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) between 18.0 and < 25.0 kg/m^2 at screening and randomization
- No prior history of regular smoking or nicotine use
- Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
- Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
- Additional criteria may apply
Key exclusion criteria (14 listed)
- Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
- Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
- Has a lifetime history of diabetes
- Has a known risk of narrow-angle glaucoma
- Has a clinically significant illness within 30 days prior to screening or admission to the clinic
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 3831Daily dosing for 21 consecutive days | Drug | ALKS 3831 |
| OlanzapineDaily dosing for 21 consecutive days | Drug | Olanzapine |
| PlaceboDaily dosing for 21 consecutive days | Drug | Placebo |
Primary outcome
Changes in blood glucose concentrations
Time frame: 21 days
Differences will be compared among treatment groups
2 secondary outcomes
Changes in insulin concentrations
Time frame: 21 days
Incidence of treatment-emergent adverse events (AEs)
Time frame: 24 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 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
David McDonnell, MD study director
Alkermes, Inc.
1 site 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 and Olanzapine in people with Healthy Volunteers, run by Alkermes, Inc. at 1 site 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 14 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Changes in blood glucose concentrations (time frame: 21 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 22 Aug 2017.