Blood Naloxone Levels Following Intradermal Injection in Humans

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: DEKA S.r.l.
• Treatments: Naloxone

Criteria

Inclusion Criteria:

• Ability to participate in the informed consent process

• Good peripheral venous access for proposed pharmacokinetic sampling

• Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer)

Exclusion Criteria:

• Allergy to Naloxone or vehicle constituents (namely parabens)

• Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation

• History of substance use disorder

• Taking opiate/opioid medications for any indication

• Chronic pain disorder

• Pregnant or breastfeeding

• Adults lacking capacity to consent, non-English speaking persons, or prisoners.

• Other medical history or active conditions deemed not safe for participation by the investigator

• Hematocrit <35%