A Pilot Study of the Bioavailability of Nasal Naloxone

NCT01939444 | Completed Phase 2 DMC

• 2 other identifiers: OPI-12-0012012-004989-18
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:

• Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
• Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
• Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
• Safety of the formulation

Conditions

Drug Overdose

Keywords

Antidotes; naloxone; administration, intravenous; administration, intranasal; pharmacology

Outcome Measures

Primary Outcomes (1)

• preliminary bioavailability of nasal naloxone

  measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.

  2 weeks

Secondary Outcomes (2)

• time to maximum concentrations

  2 weeks

• maximum concentration

  2 weeks

Study Arms (2)

naloxone intranasal

EXPERIMENTAL

2.0 mg by the nasal route

Drug: naloxone intranasal

naloxone intravenous

ACTIVE COMPARATOR

1.0 mg intravenous

Drug: naloxone intravenous

Interventions

naloxone intranasal DRUG

If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally

naloxone intranasal

naloxone intravenous DRUG

The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position

naloxone intravenous

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
• informed consent

You may not qualify if:

• history of liver disease
• taking any medications including herbal medicines the last week history of drug abuse
• any local nasal disease or nasal surgery or recent cold for the last week
• any history of drug allergies

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• University of Iceland: collaborator

Study Sites (1)

Department of circulation and medical imaging, NTNU

Trondheim, Norway

Location

Related Publications (1)

• Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.

  PMID: 31556537 RESULT

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Øyvind Ellingsen, MD PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 11, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

NO (1)