PharmacokineticsPhase 1NCT02272764
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
A Phase 1 study testing Itraconazole and ALKS 5461 in people with Pharmacokinetics, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will evaluate the impact of Itraconazole 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
- Pharmacokinetics
- What is being tested?
- Itraconazole and ALKS 5461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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 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/m2
- 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
- Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
- Is currently pregnant or breastfeeding
- Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
- Has a lifetime history of opioid abuse or dependence
- Has current abuse or dependence on alcohol or any drugs
- Has used nicotine within 90 days prior to randomization
- 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 of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
- Conditions
- Pharmacokinetics
- Being tested
- Itraconazole, ALKS 5461
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Also called Itraconazole or placebo
Administered orally in a crossover design
ALKS 5461Drug
Also called ALKS 5461 or placebo
Administered sublingually in a crossover design
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Other | Itraconazole or placebo Receives: Drug: Itraconazole |
| ALKS 5461 | Experimental | ALKS 5461 or placebo Sublingual tablet Receives: Drug: ALKS 5461 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Drug Interaction - AUC0-t
Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole
Measured: Up to 48 hours
Drug-Drug Interaction - AUC0-inf
Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Measured: Up to 48 hours
Drug-Drug Interaction - Cmax
Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
Measured: Up to 48 hours
Secondary outcomes (1)
Safety and tolerability will be measured by incidence of adverse events
Measured: Up to 32 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 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 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
- 24 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
- NCT02272764
- Sponsor's protocol ID
- ALK5461-214
- Status last verified
- Dec 2014
- First submitted
- 17 Oct 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02272764
- Acronym / sponsor ID
- ALK5461-214
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Oct 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 study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Other | Drug: ItraconazoleItraconazole or placebo |
| ALKS 5461 | Experimental | Drug: ALKS 5461ALKS 5461 or placebo Sublingual 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/m2
- 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 (7 listed)
- Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
- Is currently pregnant or breastfeeding
- Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
- Has a lifetime history of opioid abuse or dependence
- Has current abuse or dependence on alcohol or any drugs
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 |
|---|---|---|
| ItraconazoleAlso: Itraconazole or placeboAdministered orally in a crossover design | Drug | Itraconazole |
| ALKS 5461Also: ALKS 5461 or placeboAdministered sublingually in a crossover design | Drug | ALKS 5461 |
Primary outcome
Drug-Drug Interaction - AUC0-t
Time frame: Up to 48 hours
Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - AUC0-inf
Time frame: Up to 48 hours
Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Drug-Drug Interaction - Cmax
Time frame: Up to 48 hours
Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
1 secondary outcome
Safety and tolerability will be measured by incidence of adverse events
Time frame: Up to 32 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 12 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 Itraconazole and 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 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 12 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. 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?
Drug-Drug Interaction - AUC0-t (time frame: Up to 48 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 12 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.