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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 1 up to Week 12 or Week 24

Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Day 1 and Day 2

Montgomery-Asberg Depression Rating Scale (MADRS)

Timeframe: Day 1 and Day 2

Trial details

NCT IDNCT07325279

SponsorReacX Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Rajesh Patel, PhD

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

View on ClinicalTrials.gov More Opioid Abuse and Addiction trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Nalmefene Implant in Healthy Subjects

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Nalmefene Implant in Healthy Subjects

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria