Healthy VolunteersPhase 1NCT02218021
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
A Phase 1 study testing Samidorphan and Oxycodone in people with Healthy Volunteers, run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Samidorphan and Oxycodone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2014
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be in good general physical health
- Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
- Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months
- Agree to use an approved method of birth control for the duration of the study
- Additional criteria may apply
Who cannot join
- Currently pregnant or breastfeeding
- History of or current infection with hepatitis B virus, hepatitis C virus or HIV
- Current or history of any clinically significant medical or psychiatric condition
- Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
- Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
- Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Alkermes Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
- Conditions
- Healthy Volunteers
- Being tested
- Samidorphan, Placebo, Oxycodone
- Keywords
- Alkermes, ALKS 33, ALKS 5461, Samidorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamidorphanDrug
PlaceboDrug
OxycodoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Samidorphan Dose 1 | Experimental | Not described Receives: Drug: Samidorphan |
| Samidorphan Dose 2 | Experimental | Not described Receives: Drug: Samidorphan |
| Samidorphan Dose 3 | Experimental | Not described Receives: Drug: Samidorphan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Oxycodone Dose 1 | Active comparator | Not described Receives: Drug: Oxycodone |
| Oxycodone Dose 2 | Active comparator | Not described Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Measured: Approximately 4 weeks
Secondary outcomes (2)
Safety: Incidence of adverse events (AEs)
Measured: Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjeev Pathak, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218021
- Sponsor's protocol ID
- ALK33-012
- Status last verified
- Dec 2014
- First submitted
- 14 Aug 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT02218021
- Acronym / sponsor ID
- ALK33-012
- Conditions
- Healthy Volunteers
- Keywords
- Alkermes, ALKS 33, ALKS 5461, Samidorphan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Aug 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.
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Samidorphan Dose 1 | Experimental | Drug: Samidorphan |
| Samidorphan Dose 2 | Experimental | Drug: Samidorphan |
| Samidorphan Dose 3 | Experimental | Drug: Samidorphan |
| Placebo | Placebo comparator | Drug: Placebo |
| Oxycodone Dose 1 | Active comparator | Drug: Oxycodone |
| Oxycodone Dose 2 | Active comparator | Drug: Oxycodone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be in good general physical health
- Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
- Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months
- Agree to use an approved method of birth control for the duration of the study
- Additional criteria may apply
Key exclusion criteria (7 listed)
- Currently pregnant or breastfeeding
- History of or current infection with hepatitis B virus, hepatitis C virus or HIV
- Current or history of any clinically significant medical or psychiatric condition
- Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
- Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
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 |
|---|---|---|
| Samidorphan | Drug | Samidorphan Dose 1, Samidorphan Dose 2, Samidorphan Dose 3 |
| Placebo | Drug | Placebo |
| Oxycodone | Drug | Oxycodone Dose 1, Oxycodone Dose 2 |
Primary outcome
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Time frame: Approximately 4 weeks
2 secondary outcomes
Safety: Incidence of adverse events (AEs)
Time frame: Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
Time frame: Approximately 4 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 2 Dec 2014.
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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.
Sanjeev Pathak, 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 Samidorphan and Oxycodone 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 7 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 2 Dec 2014. 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?
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) (time frame: Approximately 4 weeks). 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 2 Dec 2014.