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Nalmefene Implant in Healthy Subjects

NCT07325279 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-06

No results posted yet for this study

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

Interventions

DRUG

1 Nalmefene implant

One implant

DRUG

2 Nalmefene implants

Two Implants

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • ReacX Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-23
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325279 on ClinicalTrials.gov