HealthyPhase 1NCT02413281
A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
A Phase 1 study testing ALKS 5461 and Buprenorphine in people with Healthy, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will evaluate the abuse potential of ALKS 5461. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALKS 5461 and Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2015
- 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
- Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
- Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
- Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
- Be willing and able to abide by all study requirements and restrictions
- Additional criteria may apply
Who cannot join
- Have evidence of drug or alcohol dependence within the past 2 years
- Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
- Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
- Be currently pregnant, breastfeeding, or planning to become pregnant during the study
- Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
- Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- Have donated or lost more than 500 mL whole blood
- 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 Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461
This study will evaluate the abuse potential of ALKS 5461.
- Conditions
- Healthy
- Being tested
- ALKS 5461, Buprenorphine, Placebo
- Keywords
- Healthy Volunteer, Abuse Liability, ALKS 5461, Alkermes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
Sublingual tablets, single administration
BuprenorphineDrug
Sublingual tablets, single administration
PlaceboDrug
Sublingual tablets, single administration
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461 Dose 1 | Experimental | Sublingual tablets Receives: Drug: ALKS 5461 |
| ALKS 5461 Dose 2 | Experimental | Sublingual tablets Receives: Drug: ALKS 5461 |
| ALKS 5461 Dose 3 | Experimental | Sublingual tablets Receives: Drug: ALKS 5461 |
| Buprenorphine Dose 1 | Active comparator | Sublingual tablets Receives: Drug: Buprenorphine |
| Buprenorphine Dose 2 | Active comparator | Sublingual tablets Receives: Drug: Buprenorphine |
| Placebo | Placebo comparator | Sublingual tablets Receives: Drug: Placebo |
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 14 weeks
Secondary outcomes (2)
Safety: Incidence of adverse events (AEs)
Measured: Up to 14 weeks
Pharmacokinetics: Plasma concentrations of ALKS 5461
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
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 HealthyStudies 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
- 56 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
- NCT02413281
- Sponsor's protocol ID
- ALK5461-212
- Status last verified
- Nov 2015
- First submitted
- 7 Apr 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pathak S, Vince B, Kelsh D, Shram MJ, Setnik B, Lu H, Nangia N, Stanford AD, Ehrich E. Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial. J Clin Pharmacol. 2019 Feb;59(2):206-217. doi: 10.1002/jcph.1280. Epub 2018 Aug 13.
PubMed 30102427
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461
- ClinicalTrials.gov ID
- NCT02413281
- Acronym / sponsor ID
- ALK5461-212
- Conditions
- Healthy
- Keywords
- Healthy Volunteer, Abuse Liability, ALKS 5461, Alkermes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Apr 2015 (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 abuse potential of ALKS 5461.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461 Dose 1 | Experimental | Drug: ALKS 5461Sublingual tablets |
| ALKS 5461 Dose 2 | Experimental | Drug: ALKS 5461Sublingual tablets |
| ALKS 5461 Dose 3 | Experimental | Drug: ALKS 5461Sublingual tablets |
| Buprenorphine Dose 1 | Active comparator | Drug: BuprenorphineSublingual tablets |
| Buprenorphine Dose 2 | Active comparator | Drug: BuprenorphineSublingual tablets |
| Placebo | Placebo comparator | Drug: PlaceboSublingual tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
- Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
- Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
- Be willing and able to abide by all study requirements and restrictions
- Additional criteria may apply
Key exclusion criteria (8 listed)
- Have evidence of drug or alcohol dependence within the past 2 years
- Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
- Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
- Be currently pregnant, breastfeeding, or planning to become pregnant during the study
- Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
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 5461Sublingual tablets, single administration | Drug | ALKS 5461 Dose 1, ALKS 5461 Dose 2, ALKS 5461 Dose 3 |
| BuprenorphineSublingual tablets, single administration | Drug | Buprenorphine Dose 1, Buprenorphine Dose 2 |
| PlaceboSublingual tablets, single administration | Drug | Placebo |
Primary outcome
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Time frame: Approximately 14 weeks
2 secondary outcomes
Safety: Incidence of adverse events (AEs)
Time frame: Up to 14 weeks
Pharmacokinetics: Plasma concentrations of ALKS 5461
Time frame: Up to 14 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 10 Nov 2015.
- Derived from this study: PubMed 30102427Pathak S, Vince B, Kelsh D, Shram MJ, Setnik B, Lu H, Nangia N, Stanford AD, Ehrich E. Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial. J Clin Pharmacol. 2019 Feb;59(2):206-217. doi: 10.1002/jcph.1280. Epub 2018 Aug 13.
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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 ALKS 5461 and Buprenorphine in people with Healthy, 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 8 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 10 Nov 2015. 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 14 weeks). 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 NCT02413281, 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 10 Nov 2015.