RecruitingPhase 1NCT07325279
Nalmefene Implant in Healthy Subjects
A Phase 1, Open-Label, Safety, Tolerability, and Pharmacokinetic Study of Nalmefene Implants in Healthy Subjects
Sponsor
ReacX Pharmaceuticals, Inc.
Enrollment
24 participants
Start Date
Feb 23, 2026
Study Type
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- \- 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:
- 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:
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria25
- 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.
- 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.
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Interventions
DRUG1 Nalmefene implant
One implant
DRUG2 Nalmefene implants
Two Implants
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07325279