Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02307721
• Date of registration: 23/11/2014
• Prospective Registration: Yes
• Primary sponsor: Norwegian University of Science and Technology
• Public title: Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use OPI-14-001
• Scientific title: Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use
• Date of first enrolment: December 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02307721
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Toril A Nagelhus Hernes, phd prof
• Affiliation: Norwegian University of Science and Technology

Key inclusion & exclusion criteria

Inclusion Criteria:

- American Society of Anesthesiologists (ASA) class I

- ECG without pathologic abnormalities

- BMI range of 18,5 - 24,9 kg/m2.

- lab values within reference values at St Olav's Hospital for the relevant
haematological and biochemical test for inclusion:

- Haemoglobin (male: 13.4-17.0 g/dL, female 11.7 - 15.3 g/dL)

- Creatinine (male: 60-105 micromole/L, female 45 - 90 micromole/L)

- Aspartate aminotransferases (ASAT) (male: 15-45 U/L, female: 15-35 U/L)

- Alanine transaminase (ALAT) (male: 10-70 U/L, female: 10-45 U/L)

- Gamma glutamyl transpeptidase (GT) (male: 10-80 U/L, female: 10-45 U/L)

- For women in reproductive age: serum HCG (normal under 3 ye/L)

- Signed informed consent and expected cooperation of the subjects for the treatment

Exclusion Criteria:

- Taking any medications including herbal medicines the last week prior to treatment
visits

- Current or history of drug and/or alcohol abuse (To assess problematic drug or alcohol
use we use the CAGE AID screening tool)

- History of contact with police or authorities in relation to alcohol or drug offences

- History of prolonged use of opioid analgesics

- History of prior drug allergy

- Having any local nasal disease or nasal surgery for the last 2 months or recent cold
for the last week

- Pregnant women (HCG over 3 ye/L at inclusion)

- Women in reproductive age not using high efficacy contraceptives (Oral contraceptives,
Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper intra-uterine device (IUD),
Sterilization) throughout the study period until their last visit.

- Breastfeeding women

- Participants with access to remifentanil or other potent opioids in their daily
workplace.

- Hypersensitivity to naloxone or remifentanil hydrochloride and/or to any of its
excipients.

- Any reason why, in the opinion of the investigator, the patient should not
participate.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Drug Overdose

Intervention(s)

Drug: Remifentanil

Device: Aptar Unidose

Drug: Intranasal naloxone

Drug: Intramuscular naloxone

Primary Outcome(s)

Pharmacodynamic profile of naloxone. Pupillometry [Time Frame: 120 minutes]

Pharmacodynamic profile of naloxone- Heat Pain Threshold [Time Frame: 120 minutes]

Secondary Outcome(s)

Pharmacokinetics: time to maximum concentration (Tmax) of IN and IM naloxone [Time Frame: 360 minutes]

Adverse Events [Time Frame: minimum 6 days]

Pharmacokinetics: Area Under the Curve of IN and IM naloxone [Time Frame: 360 minutes]

Pharmacokinetics: maximum concentration (Cmax) of IN and IM naloxone [Time Frame: 360 minutes]

Quantitate serum concentrations of remifentanil at specified time points [Time Frame: 110 minutes]

Suitability of spray device in prehospital setting [Time Frame: 100 minutes]

Secondary ID(s)

2014-001465-27

OPI-14-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital