HealthyPhase 1NCT02521857
A Water Consumption Study of ALKS 5461 in Healthy Volunteers
A Phase 1 study testing ALKS 5461 in people with Healthy, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALKS 5461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
- Is in good physical health
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
Who cannot join
- Is currently pregnant or breastfeeding
- Has a history of substance abuse disorder
- Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
- Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
- Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
- Has used alcohol within 72 hours prior to any inpatient period
Show all 9Show fewer
- Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
- Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
- 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 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461
This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.
- Conditions
- Healthy
- Being tested
- ALKS 5461
- Keywords
- Alkermes, Samidorphan, ALKS 5461, Healthy Volunteer, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461 | Experimental | Sublingual tablet Receives: Drug: ALKS 5461 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Measured: Up to 72 hours
AUClast
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Measured: Up to 72 hours
Cmax
Maximum observed plasma concentration for ALKS 5461
Measured: Up to 72 hours
Secondary outcomes (1)
Safety and tolerability will be measured by the incidence of Adverse Effects
Measured: Up to 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arielle Stanford, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521857
- Sponsor's protocol ID
- ALK5461-A110
- Status last verified
- Nov 2015
- First submitted
- 11 Aug 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461
- ClinicalTrials.gov ID
- NCT02521857
- Acronym / sponsor ID
- ALK5461-A110
- Conditions
- Healthy
- Keywords
- Alkermes, Samidorphan, ALKS 5461, Healthy Volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 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 impact of water consumption on the pharmacokinetics of ALKS 5461.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461 | Experimental | Drug: ALKS 5461Sublingual tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
- Is in good physical health
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
Key exclusion criteria (9 listed)
- Is currently pregnant or breastfeeding
- Has a history of substance abuse disorder
- Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
- Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
- Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
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 tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints | Drug | ALKS 5461 |
Primary outcome
AUCinf
Time frame: Up to 72 hours
Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
AUClast
Time frame: Up to 72 hours
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Cmax
Time frame: Up to 72 hours
Maximum observed plasma concentration for ALKS 5461
1 secondary outcome
Safety and tolerability will be measured by the incidence of Adverse Effects
Time frame: Up to 46 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 10 Nov 2015.
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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.
Arielle Stanford, 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 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 4 inclusion and 9 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. 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?
AUCinf (time frame: Up to 72 hours). The study lists 3 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 10 Nov 2015.