Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Knoa Pharma LLC
Study ID
NCT07543276
Phase
PHASE1
Status
Completed

Conditions

  • Opioid Overdose

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Nalmefene + 0.94% MgCl2 — DRUG
    Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration
  • Nalmefene + 0.94% MgCl2 — DRUG
    Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration
  • Nalmefene Hydrochloride Injection — DRUG
    Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration

Study Details

This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.

Key Dates

Start date
Feb 6, 2026
Status verified
Jun 2026
Primary completion
Apr 3, 2026
Completion
Apr 3, 2026

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Nalmefene + 0.94% MgCl2 (IV)
  • Experimental: Treatment B
    Nalmefene + 0.94% MgCl2 (IM)
  • Active Comparator: Treatment C
    Nalmefene Hydrochloride injection

Primary Outcome Measure

Area Under the Curve (AUC0-2.5) [ Time Frame: 2.5 minutes post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio Clinical TrialsColumbusOhio43212-

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By research site
Ohio Clinical Trials· Columbus, OH

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