HealthyPhase 1NCT02504463
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
A Phase 1 study testing Samidorphan IV, [14c]-Samidorphan sublingual and [14c]-Samidorphan oral in people with Healthy, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Samidorphan IV, [14c]-Samidorphan sublingual and [14c]-Samidorphan oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m^2 at screening (minimum weight of 50.0 kg)
- Generally good health
- Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
- Additional criteria may apply
Who cannot join
- Clinically significant illness within 30 days
- History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
- History of oral or gastrointestinal disease
- Irregular bowel or bladder function
- History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
- Current or pending legal charges or probation that would interfere with study conduct
Show all 10Show fewer
- Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
- Tobacco or nicotine use within 90 days
- Anticipated need for prescription medicines during the study period
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects
This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Samidorphan IV, [14c]-Samidorphan sublingual, [14c]-Samidorphan oral
- Keywords
- Alkermes, Samidorphan, ALKS 33, Healthy Volunteer, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samidorphan IVDrug
Single IV administration
[14c]-Samidorphan sublingualDrug
Single sublingual administration containing radiolabel
[14c]-Samidorphan oralDrug
Single oral administration containing radiolabel
| Study group | Role | What they receive |
|---|---|---|
| Samidorphan IV | Experimental | Samidorphan solution for IV administration Receives: Drug: Samidorphan IV |
| Samidorphan sublingual | Experimental | [14c]-Samidorphan for sublingual administration Receives: Drug: [14c]-Samidorphan sublingual |
| Samidorphan oral | Experimental | [14c]-Samidorphan for oral administration Receives: Drug: [14c]-Samidorphan oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Measured: Up to 120 hours after each dose
Cmax
Maximum concentration of total radioactivity in blood and plasma
Measured: Up to 120 hours after each dose
Tmax
Time to maximum concentration of total radioactivity in blood and plasma
Measured: Up to 120 hours after each dose
Fe%0-t
Fraction of dose excreted in urine and feces
Measured: Up to 120 hours after each dose
Secondary outcomes (1)
Safety and tolerability will be measured by the incidence of Adverse Events
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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 Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504463
- Sponsor's protocol ID
- ALK33-B107
- Status last verified
- Sep 2015
- First submitted
- 6 Jul 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02504463
- Acronym / sponsor ID
- ALK33-B107
- Conditions
- Healthy
- Keywords
- Alkermes, Samidorphan, ALKS 33, Healthy Volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jul 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 determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Samidorphan IV | Experimental | Drug: Samidorphan IVSamidorphan solution for IV administration |
| Samidorphan sublingual | Experimental | Drug: [14c]-Samidorphan sublingual[14c]-Samidorphan for sublingual administration |
| Samidorphan oral | Experimental | Drug: [14c]-Samidorphan oral[14c]-Samidorphan for oral administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m^2 at screening (minimum weight of 50.0 kg)
- Generally good health
- Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
- Additional criteria may apply
Key exclusion criteria (10 listed)
- Clinically significant illness within 30 days
- History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
- History of oral or gastrointestinal disease
- Irregular bowel or bladder function
- History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
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 |
|---|---|---|
| Samidorphan IVSingle IV administration | Drug | Samidorphan IV |
| [14c]-Samidorphan sublingualSingle sublingual administration containing radiolabel | Drug | Samidorphan sublingual |
| [14c]-Samidorphan oralSingle oral administration containing radiolabel | Drug | Samidorphan oral |
Primary outcome
AUC 0-t
Time frame: Up to 120 hours after each dose
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Cmax
Time frame: Up to 120 hours after each dose
Maximum concentration of total radioactivity in blood and plasma
Tmax
Time frame: Up to 120 hours after each dose
Time to maximum concentration of total radioactivity in blood and plasma
Fe%0-t
Time frame: Up to 120 hours after each dose
Fraction of dose excreted in urine and feces
1 secondary outcome
Safety and tolerability will be measured by the incidence of Adverse Events
Time frame: Up to 35 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 18 Sep 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 Medical Director
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 Samidorphan IV, [14c]-Samidorphan sublingual and [14c]-Samidorphan oral 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 18 Sep 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?
AUC 0-t (time frame: Up to 120 hours after each dose). The study lists 4 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 18 Sep 2015.