PharmacokineticsPhase 1NCT02068105
A Study of ALKS 5461 in Healthy Volunteers
A Phase 1 study testing ALKS 5461 in people with Pharmacokinetics, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This is a study to test the safety of ALKS 5461 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- ALKS 5461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be in good physical health
- Body mass index of 18-30 kg/m2
- 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 Human Immunodeficiency Virus (HIV)
- Current or history of any clinically significant medical or psychiatric condition
- Current abuse or dependence on alcohol or any illicit drugs
- Have used nicotine within 90 days
- Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
Show all 10Show fewer
- 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 used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
- Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, 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, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects
This is a study to test the safety of ALKS 5461 in healthy adults.
- Conditions
- Pharmacokinetics
- Being tested
- ALKS 5461, Placebo
- Keywords
- ALKS 5461, samidorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
Sublingual tablet
PlaceboDrug
Sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461-A | Experimental | Not described Receives: Drug: ALKS 5461 |
| ALKS 5461-B | Experimental | Not described Receives: Drug: ALKS 5461 |
| ALKS 5461 Dose 1 | Experimental | Not described Receives: Drug: ALKS 5461 |
| ALKS 5461 Dose 2 | Experimental | Not described Receives: Drug: ALKS 5461 |
| ALKS 5461 Dose 3 | Experimental | Not described Receives: Drug: ALKS 5461 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of ALKS 5461 treatment groups
The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).
Measured: 21 days
Secondary outcomes (1)
Safety and tolerability: Incidence of adverse events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Marshall, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068105
- Sponsor's protocol ID
- ALK5461-209
- Status last verified
- Apr 2014
- First submitted
- 12 Feb 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02068105
- Acronym / sponsor ID
- ALK5461-209
- Conditions
- Pharmacokinetics
- Keywords
- ALKS 5461, samidorphan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Feb 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.
This is a study to test the safety of ALKS 5461 in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461-A | Experimental | Drug: ALKS 5461 |
| ALKS 5461-B | Experimental | Drug: ALKS 5461 |
| ALKS 5461 Dose 1 | Experimental | Drug: ALKS 5461 |
| ALKS 5461 Dose 2 | Experimental | Drug: ALKS 5461 |
| ALKS 5461 Dose 3 | Experimental | Drug: ALKS 5461 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be in good physical health
- Body mass index of 18-30 kg/m2
- Agree to use an approved method of birth control for the duration of the study
- Additional criteria may apply
Key exclusion criteria (10 listed)
- Currently pregnant or breastfeeding
- History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
- Current or history of any clinically significant medical or psychiatric condition
- Current abuse or dependence on alcohol or any illicit drugs
- Have used nicotine within 90 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 |
|---|---|---|
| ALKS 5461Sublingual tablet | Drug | ALKS 5461 Dose 1, ALKS 5461 Dose 2, ALKS 5461 Dose 3, ALKS 5461-A, ALKS 5461-B |
| PlaceboSublingual tablet | Drug | Placebo |
Primary outcome
Relative bioavailability of ALKS 5461 treatment groups
Time frame: 21 days
The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).
1 secondary outcome
Safety and tolerability: Incidence of adverse events
Time frame: 21 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 21 Apr 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.
Randall Marshall, 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 Pharmacokinetics, 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 10 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 21 Apr 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?
Relative bioavailability of ALKS 5461 treatment groups (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 21 Apr 2014.