Nalmefene Implant in Healthy Subjects (NCT07325279) | Clinical Trial Compass
RecruitingPhase 1
Nalmefene Implant in Healthy Subjects
United States24 participantsStarted 2026-02-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.
✕. 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