Nalmefene implant in healthy volunteers

A Phase 1, Open-Label, Safety, Tolerability, and Pharmacokinetic Study of Nalmefene Implants in Healthy Subjects

This Phase 1 trial will test one or two nalmefene implants in healthy adults to see how safe they are and how the drug is absorbed and cleared from the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ReacX Pharmaceuticals, Inc. (industry)
• Locations: 1 site (Morrisville, North Carolina)
• Trial ID: NCT07325279 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label Phase 1 trial in healthy adults designed to compare one versus two subcutaneous nalmefene implants for safety, tolerability, and pharmacokinetics. Enrollment is initially limited to the one-implant cohort until a Safety Review Committee reviews safety data through Week 4, after which a two-implant cohort may open. Participants undergo screening, an implant insertion visit with short inpatient confinement, multiple outpatient visits for PK and safety sampling, and implant removal around Week 12 with follow-up. Data from this healthy volunteer study will guide dosing and design for future trials in patients with opioid use disorders.

Who should consider this trial

Good fit: Healthy non-smoking adults aged 18–55 with BMI >18.5 and <35 kg/m2 (and meeting the study's weight and reproductive-status criteria) are the intended participants.

Not a fit: People with active opioid use disorder, those who require opioid medications, pregnant or breastfeeding women, smokers, or individuals outside the age/BMI limits are unlikely to receive direct clinical benefit from this Phase 1 healthy-volunteer trial.

Why it matters

Potential benefit: If successful, an implantable nalmefene product could provide a long-acting opioid antagonist option that reduces the need for daily dosing and may help prevent relapse.

How similar studies have performed: Long-acting opioid antagonist formulations such as injectable or implanted naltrexone have shown some clinical benefit, but nalmefene implants themselves have limited prior data and represent a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

\- Subjects must meet all of the following criteria to be included in the study:

1. 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.
2. Healthy as defined by:

   1. the absence of clinically significant illness and surgery within 4 weeks prior to implant insertion.
   2. the absence of clinically significant history of dermatologic, neurological, musculoskeletal, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. Female subjects of non-childbearing potential must be:

   1. post-menopausal with confirmation by documented follicle-stimulating hormone (FSH) test; or
   2. surgically sterile .
4. 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:
5. 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.

Exclusion Criteria:

* Subjects to whom any of the following applies will be excluded from the study:

  1. Any clinically significant abnormal finding at physical examination at screening.
  2. Clinically significant history of or current evidence of suicidal ideation or active suicidal behavior as based on the C-SSRS.
  3. Clinically significant history or current evidence of depression as based on the MADRS.
  4. 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.
  5. Positive pregnancy test or lactating female subject.
  6. Positive urine drug screen, urine cotinine test, or alcohol breath test.
  7. Known medically significant intolerance or allergic reactions to nalmefene or to ethylene vinyl acetate
  8. Hypersensitivity to lidocaine or other local anesthetics of the amide type, epinephrine, antiseptic solution
  9. Clinically significant ECG abnormalities or vital signs abnormalities
  10. History of drug use within 1 year prior to screening or recreational use of marijuana within 1 month
  11. History of alcohol abuse within 1 year prior to screening
  12. Use of medications for the timeframes specified below:

      1. depot injection or implant within 3 months prior to implant insertion;
      2. any drug known to induce hepatic drug metabolism within 30 days prior to implant insertion;
      3. prescription medications within 14 days prior to implant insertion;
      4. any vaccine within 14 days prior to implant insertion;
      5. over-the-counter medications and natural health products within 7 days prior to implant insertion
  13. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to implant insertion,
  14. Donation of plasma within 7 days prior to dosing or donation or
  15. Intolerant to venipuncture and/or have difficulty with venous access.
  16. History of wound healing problems.
  17. Lymphedema, scarring, or tattoos on his/her inner upper arms within 2 months prior to screening or a history of keloid scarring.
  18. Any dermatologic disorder, including cancer, that precludes the safety of the implant
  19. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Where this trial is running

Morrisville, North Carolina

• Premier Research — Morrisville, North Carolina, United States (RECRUITING)

Study contacts

• Study coordinator: Rajesh Patel, PhD

Conditions: Opioid Abuse and Addiction, nalmefene implant opioid addition