HealthyPhase 1NCT02479308
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
A Phase 1 study testing Moxifloxacin and ALKS 5461 in people with Healthy, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability 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?
- Moxifloxacin and ALKS 5461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Oct 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
- Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening
- Is physically healthy
- Agree to abide by the contraception requirements for the duration of the study
- Additional criteria may apply
Who cannot join
- Have a positive pregnancy test and/or be currently breastfeeding
- Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
- Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
- Have any skin condition likely to interfere with ECG electrode placement or adhesion
- Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
- Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose
Show all 10Show fewer
- Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose
- Have used nicotine within 90 days prior to the first study drug dose
- Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study
- 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: The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
- Conditions
- Healthy
- Being tested
- Moxifloxacin, ALKS 5461, Placebo
- Keywords
- Alkermes, Samidorphan, ALKS 5461, QT/QTc, Buprenorphine, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Single administration
ALKS 5461Drug
Daily administration for a total of 12 dosing days
PlaceboDrug
Placebo will be matched to Moxifloxacin or ALKS 5461
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Active comparator | Oral tablet Receives: Drug: Moxifloxacin |
| ALKS 5461 | Experimental | Sublingual tablet 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.
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Measured: Up to 14 days
Secondary outcomes (12)
Change in heart rate
Measured: Up to 14 days
Incidence of abnormal ECG
Measured: Up to 13 days
Tabulation of ECG morphology
Findings not present at baseline
Measured: Up to 14 days
Correlation of plasma drug levels with QT interval
Measured: Up to 14 days
Maximum observed plasma concentration (Cmax) for ALKS 5461
Measured: Up to 14 days
Incidence of adverse events (AEs)
Measured: Up to 14 weeks
Change in PR interval
Measured: Up to 14 days
Change in QRS interval
Measured: Up to 14 days
Time to reach the maximum plasma concentration (Tmax) for ALKS 5461
Measured: Up to 14 days
AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Measured: Up to 14 days
AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Measured: Up to 14 days
Terminal elimination half-life (T1/2) for ALKS 5461
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 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.Arielle Stanford, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479308
- Sponsor's protocol ID
- ALK5461-213
- Status last verified
- Nov 2015
- First submitted
- 5 Jun 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02479308
- Acronym / sponsor ID
- ALK5461-213
- Conditions
- Healthy
- Keywords
- Alkermes, Samidorphan, ALKS 5461, QT/QTc, Buprenorphine, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Jun 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 effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Active comparator | Drug: MoxifloxacinOral tablet |
| ALKS 5461 | Experimental | Drug: ALKS 5461Sublingual tablet |
| 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)
- Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening
- Is physically healthy
- Agree to abide by the contraception requirements for the duration of the study
- Additional criteria may apply
Key exclusion criteria (10 listed)
- Have a positive pregnancy test and/or be currently breastfeeding
- Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
- Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
- Have any skin condition likely to interfere with ECG electrode placement or adhesion
- Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
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 |
|---|---|---|
| MoxifloxacinSingle administration | Drug | Moxifloxacin |
| ALKS 5461Daily administration for a total of 12 dosing days | Drug | ALKS 5461 |
| PlaceboPlacebo will be matched to Moxifloxacin or ALKS 5461 | Drug | Placebo |
Primary outcome
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Time frame: Up to 14 days
12 secondary outcomes
Change in heart rate
Time frame: Up to 14 days
Incidence of abnormal ECG
Time frame: Up to 13 days
Tabulation of ECG morphology
Time frame: Up to 14 days
Correlation of plasma drug levels with QT interval
Time frame: Up to 14 days
Maximum observed plasma concentration (Cmax) for ALKS 5461
Time frame: Up to 14 days
Incidence of adverse events (AEs)
Time frame: Up to 14 weeks
Change in PR interval
Time frame: Up to 14 days
Change in QRS interval
Time frame: Up to 14 days
Time to reach the maximum plasma concentration (Tmax) for ALKS 5461
Time frame: Up to 14 days
AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Time frame: Up to 14 days
AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Time frame: Up to 14 days
Terminal elimination half-life (T1/2) for ALKS 5461
Time frame: Up to 14 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 23 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.
Sanjeev Pathak, MD study director
Alkermes, Inc.
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 Moxifloxacin and 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 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 23 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?
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF) (time frame: Up to 14 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 23 Nov 2015.