A Pilot Study of the Bioavailability of Nasal Naloxone

Drug Overdose Clinical Trial

Official title:

A Pilot Study of the Bioavailability of Nasal Naloxone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939444
• Other study ID #: OPI-12-001
• Secondary ID: 2012-004989-18
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Drug Overdose

Intervention

Drug:
• naloxone intranasal
If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
• naloxone intravenous
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

Locations

Country	Name	City	State
Norway	Department of circulation and medical imaging, NTNU	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, University of Iceland

Country where clinical trial is conducted

Norway, 

References & 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. Norwegian, English. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to maximum concentrations		2 weeks
Secondary	maximum concentration		2 weeks