Hepatic ImpairmentPhase 1NCT02452801
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing ALKS 5461 in people with Hepatic Impairment, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
- For subjects with hepatic impairment:
- Has mild, moderate, or severe hepatic impairment
- Has hepatic dysfunction due to hepatocellular disease
- Additional criteria may apply
Who cannot join
- For all subjects:
- Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than hepatic impairment
- Has a history of gastrointestinal surgery, excluding appendectomy or cholecystectomy
- Is pregnant, planning to become pregnant, or lactating
- Has a history of clinically significant allergy or a hypersensitivity to opioids
- Additional criteria may apply
Show all 11Show fewer
- For subjects with hepatic impairment:
- Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition
- Has received a liver transplant
- Has had esophageal variceal bleeding in the past 2 months
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Alkermes Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.
- Conditions
- Hepatic Impairment
- Being tested
- ALKS 5461
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
Single dose, given orally
| 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.
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
Measured: Up to 168 hours postdose
Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461
Measured: Up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
Measured: Up to 168 hours postdose
Secondary outcomes (5)
Time to reach maximum plasma concentration (TMAX)
Measured: Up to 168 hours postdose
Terminal elimination half-life (T1/2)
Measured: Up to 168 hours postdose
Apparent clearance (CL/F)
Measured: Up to 168 hours postdose
Apparent volume of distribution (Vz/F)
Measured: Up to 168 hours postdose
Incidence of adverse events (AEs)
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 posted25 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- 40 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
- NCT02452801
- Sponsor's protocol ID
- ALK5461-215
- Status last verified
- Feb 2016
- First submitted
- 21 May 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT02452801
- Acronym / sponsor ID
- ALK5461-215
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 May 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 effect of various degrees of hepatic function on the pharmacokinetics and safety 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 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
- Has mild, moderate, or severe hepatic impairment
- Has hepatic dysfunction due to hepatocellular disease
Key exclusion criteria (11 listed)
- Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than hepatic impairment
- Has a history of gastrointestinal surgery, excluding appendectomy or cholecystectomy
- Is pregnant, planning to become pregnant, or lactating
- Has a history of clinically significant allergy or a hypersensitivity to opioids
- Additional criteria may apply
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 5461Single dose, given orally | Drug | ALKS 5461 |
Primary outcome
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
Time frame: Up to 168 hours postdose
Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461
Time frame: Up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
Time frame: Up to 168 hours postdose
5 secondary outcomes
Time to reach maximum plasma concentration (TMAX)
Time frame: Up to 168 hours postdose
Terminal elimination half-life (T1/2)
Time frame: Up to 168 hours postdose
Apparent clearance (CL/F)
Time frame: Up to 168 hours postdose
Apparent volume of distribution (Vz/F)
Time frame: Up to 168 hours postdose
Incidence of adverse events (AEs)
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 4 Feb 2016.
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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 in people with Hepatic Impairment, 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 8 inclusion and 11 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 4 Feb 2016. 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?
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461 (time frame: Up to 168 hours postdose). 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 4 Feb 2016.