Opioid Abuse and AddictionPhase 1NCT07325279
Nalmefene Implant in Healthy Subjects
A Phase 1 study testing 1 Nalmefene implant and 2 Nalmefene implants in people with Opioid Abuse and Addiction, run by ReacX Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks. Additionally the pharmacokinetics (PK), how fast the drug is absorbed into the body and how long it remains in the body, will also be studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse and Addiction
- What is being tested?
- 1 Nalmefene implant and 2 Nalmefene implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Male or female, non-smoker, ≥18 and ≤55 years of age, with body mass index (BMI) >18.5 and <35.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to implant insertion.
- the absence of clinically significant history of dermatologic, neurological, musculoskeletal, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Female subjects of non-childbearing potential must be:
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- post-menopausal with confirmation by documented follicle-stimulating hormone (FSH) test; or
- surgically sterile .
- Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be willing to use an acceptable contraceptive methods throughout the study and for 30 days after the implant is removed:
- Male subjects who are not vasectomized for at least 3 months prior to implant insertion and who are sexually active with a female partner of childbearing potential must be willing to use an acceptable contraceptive methods from implant insertion and for 30 days after the implant is removed:
- 6 Able to understand the study procedures and provide signed informed consent to participate in the study.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Any clinically significant abnormal finding at physical examination at screening.
- Clinically significant history of or current evidence of suicidal ideation or active suicidal behavior as based on the C-SSRS.
- Clinically significant history or current evidence of depression as based on the MADRS.
- Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
- Positive pregnancy test or lactating female subject.
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- Positive urine drug screen, urine cotinine test, or alcohol breath test.
- Known medically significant intolerance or allergic reactions to nalmefene or to ethylene vinyl acetate
- Hypersensitivity to lidocaine or other local anesthetics of the amide type, epinephrine, antiseptic solution
- Clinically significant ECG abnormalities or vital signs abnormalities
- History of drug use within 1 year prior to screening or recreational use of marijuana within 1 month
- History of alcohol abuse within 1 year prior to screening
- Use of medications for the timeframes specified below:
- depot injection or implant within 3 months prior to implant insertion;
- any drug known to induce hepatic drug metabolism within 30 days prior to implant insertion;
- prescription medications within 14 days prior to implant insertion;
- any vaccine within 14 days prior to implant insertion;
- over-the-counter medications and natural health products within 7 days prior to implant insertion
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to implant insertion,
- Donation of plasma within 7 days prior to dosing or donation or
- Intolerant to venipuncture and/or have difficulty with venous access.
- History of wound healing problems.
- Lymphedema, scarring, or tattoos on his/her inner upper arms within 2 months prior to screening or a history of keloid scarring.
- Any dermatologic disorder, including cancer, that precludes the safety of the implant
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susan Lee contact
United States1 site, 1 recruiting
- Recruiting
Premier Research
Morrisville, North Carolina, 27560
About this study
Official title: A Phase 1, Open-Label, Safety, Tolerability, and Pharmacokinetic Study of Nalmefene Implants in Healthy Subjects
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks.
Additionally the pharmacokinetics (PK), how fast the drug is absorbed into the body and how long it remains in the body, will also be studies.
The data collected in this healthy volunteer study will inform the Sponsor on how best to proceed with future trials in the intended patient population.
Read the detailed description
This is a single center, Phase 1, open-label, safety, tolerability, and PK study designed to compare one (1) or two (2) nalmefene implants in healthy subjects.
The study will include a screening period from Day -28 to Day -2, where subjects will be evaluated according to the Inclusion/Exclusion Criteria. Enrollment will be initially restricted to Cohort 1 (1 implant) until the Safety Review Committee (SRC) completes an evaluation of the safety data, of at least 5 subjects, through the Week 4 Visit. The SRC will then advise the Sponsor as to whether to open enrollment to Cohort 2 (2 implants).
Including screening, the first 8 subjects will be enrolled into Cohort 1 Subgroup 1 and will be seen for 16 visits over a period of up to 18 weeks. This includes a total of up to 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, and 10. Subjects will be admitted again two days prior to the Week 12/End of Treatment for an implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 13 and Week 14 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
Including screening, subjects enrolled into Cohort 1 Subgroup 2 and Cohort 2 will be seen for approximately 22 visits over a period of up to 30 weeks. This includes a total of 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22. Subjects will be admitted again on the day prior to the Week 24/EOT implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 25 and Week 26 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
- Conditions
- Opioid Abuse and Addiction
- Being tested
- 1 Nalmefene implant, 2 Nalmefene implants
- Keywords
- nalmefene implant opioid addition
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Nalmefene implantDrug
One implant
2 Nalmefene implantsDrug
Two Implants
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1; 1 Implant | Active comparator | Not described Receives: Drug: 1 Nalmefene implant |
| Cohort 2; 2 Implants | Active comparator | Not described Receives: Drug: 2 Nalmefene implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.
Measured: Day 1 up to Week 12 or Week 24
Columbia-Suicide Severity Rating Scale (C-SSRS)
Questionnaire
Measured: Day 1 and Day 2
Montgomery-Asberg Depression Rating Scale (MADRS)
Questionnaire
Measured: Day 1 and Day 2
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of nalmefene after implantation with 1 or 2 nalmefene implants.
PK blood sample
Measured: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Area under the concentration curve (AUC) after implantation with 1 or 2 nalmefene implants
PK blood sample
Measured: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Plasma concertation of nalmefene after implantation with 1 or 2 nalmefene implants
PK blood sample
Measured: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start23 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse and AddictionStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReacX Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325279
- Sponsor's protocol ID
- NI-001
- Other IDs
- 5UGDA047707-02
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Safety, Tolerability, and Pharmacokinetic Study of Nalmefene Implants in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07325279
- Acronym / sponsor ID
- NI-001
- Conditions
- Opioid Abuse and Addiction
- Keywords
- nalmefene implant opioid addition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ReacX Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- 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.
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks.
Additionally the pharmacokinetics (PK), how fast the drug is absorbed into the body and how long it remains in the body, will also be studies.
The data collected in this healthy volunteer study will inform the Sponsor on how best to proceed with future trials in the intended patient population.
Detailed description
This is a single center, Phase 1, open-label, safety, tolerability, and PK study designed to compare one (1) or two (2) nalmefene implants in healthy subjects.
The study will include a screening period from Day -28 to Day -2, where subjects will be evaluated according to the Inclusion/Exclusion Criteria. Enrollment will be initially restricted to Cohort 1 (1 implant) until the Safety Review Committee (SRC) completes an evaluation of the safety data, of at least 5 subjects, through the Week 4 Visit. The SRC will then advise the Sponsor as to whether to open enrollment to Cohort 2 (2 implants).
Including screening, the first 8 subjects will be enrolled into Cohort 1 Subgroup 1 and will be seen for 16 visits over a period of up to 18 weeks. This includes a total of up to 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, and 10. Subjects will be admitted again two days prior to the Week 12/End of Treatment for an implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 13 and Week 14 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
Including screening, subjects enrolled into Cohort 1 Subgroup 2 and Cohort 2 will be seen for approximately 22 visits over a period of up to 30 weeks. This includes a total of 8 nights of inpatient stay during that period. Eligible subjects will be admitted to the clinical site on Day -1 and implant insertion will occur on Day 1. Subjects will be confined until completion of the assessments on Day 2. Subjects will return to the clinical site for outpatient visits on Days 3 and 4, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22. Subjects will be admitted again on the day prior to the Week 24/EOT implant removal visit and will be discharged after the final blood sample is collected 72 hours after implant removal. Subjects will return to the clinical site for follow-up visits on Week 25 and Week 26 (1 and 2 week(s) following implant removal procedure) for removal of sutures (if any) and safety evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1; 1 Implant | Active comparator | Drug: 1 Nalmefene implant |
| Cohort 2; 2 Implants | Active comparator | Drug: 2 Nalmefene implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria to be included in the study:
- Male or female, non-smoker, ≥18 and ≤55 years of age, with body mass index (BMI) >18.5 and <35.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Healthy as defined by:
- Female subjects of non-childbearing potential must be:
- Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be willing to use an acceptable contraceptive methods throughout the study and for 30 days after the implant is removed:
Key exclusion criteria (25 listed)
- Subjects to whom any of the following applies will be excluded from the study:
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 |
|---|---|---|
| 1 Nalmefene implantOne implant | Drug | Cohort 1; 1 Implant |
| 2 Nalmefene implantsTwo Implants | Drug | Cohort 2; 2 Implants |
Primary outcome
Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.
Time frame: Day 1 up to Week 12 or Week 24
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 1 and Day 2
Questionnaire
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Day 1 and Day 2
Questionnaire
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of nalmefene after implantation with 1 or 2 nalmefene implants.
Time frame: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Area under the concentration curve (AUC) after implantation with 1 or 2 nalmefene implants
Time frame: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Plasma concertation of nalmefene after implantation with 1 or 2 nalmefene implants
Time frame: Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Susan Lee contact
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 1 Nalmefene implant and 2 Nalmefene implants in people with Opioid Abuse and Addiction, run by ReacX Pharmaceuticals, 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 11 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Patel, PhD (1-833-824-0824, rpatel@reacxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants. (time frame: Day 1 up to Week 12 or Week 24). 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 6 Apr 2026.