Nalmefene Implant in Healthy Subjects

NCT07325279 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: NI-0015UGDA047707-02
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Opioid Abuse and Addiction

Keywords

nalmefene implant opioid addition

Outcome Measures

Primary Outcomes (3)

• Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants.

  Day 1 up to Week 12 or Week 24

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Questionnaire

  Day 1 and Day 2

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Questionnaire

  Day 1 and Day 2

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of nalmefene after implantation with 1 or 2 nalmefene implants.

  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

  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

  Day 1, 2, 3, 4, Weeks 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 22, 24, 25, 26

Study Arms (2)

Cohort 1; 1 Implant

ACTIVE COMPARATOR

Drug: 1 Nalmefene implant

Cohort 2; 2 Implants

ACTIVE COMPARATOR

Drug: 2 Nalmefene implants

Interventions

1 Nalmefene implant DRUG

One implant

Cohort 1; 1 Implant

2 Nalmefene implants DRUG

Two Implants

Cohort 2; 2 Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ReacX Pharmaceuticals, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Rajesh Patel, PhD

CONTACT

1-833-824-0824; rpatel@reacxpharma.com

Susan Lee

CONTACT

slee@reacxpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 8, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share