Nalmefene Implant in Healthy Subjects

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
ReacX Pharmaceuticals, Inc.
Study ID
NCT07325279
Phase
PHASE1
Status
Recruiting
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Conditions

  • Opioid Abuse and Addiction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 1 Nalmefene implant — DRUG
    One implant
  • 2 Nalmefene implants — DRUG
    Two Implants

Study Details

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.

Key Dates

Start date
Feb 23, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1; 1 Implant
  • Active Comparator: Cohort 2; 2 Implants

Primary Outcome Measure

Number of participants with Adverse Events (AEs) after implantation with 1 or 2 nalmefene implants. [ Time Frame: Day 1 up to Week 12 or Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Premier ResearchMorrisvilleNorth Carolina27560-

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Premier Research· Morrisville, NC

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