Pharmacodynamic Evaluation of Intranasal Nalmefene

Pharmacodynamic Clinical Trial

Official title:

A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828005
• Other study ID #: OPNT003-PD-001
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: December 2022
• Source: Opiant Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.

Description:

Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure. Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18 to 55 years inclusive
• BMI ranging from 18 to 32 kg/m2, inclusive
• Adequate venous access
• Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening

Exclusion Criteria:

• History of clinically significant disease
• Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
• Subject who has a difficult airway for intubation.
• Following an abnormal diet 4 weeks prior to screening
• Use of over-the-counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
• Use of enzyme altering drugs 30 days before intervention
• Use of nasal products 28 days before intervention and throughout the study
• Previous or current opioid, alcohol, or other drug dependence
• Donated or received blood 30 days before intervention
• Women who are pregnant or breastfeeding at screening
• Women of childbearing potential unless surgically sterile or use effective contraception
• Current or recent upper respiratory tract infection
• Allergic to nalmefene or naloxone or known hypersensitivity reaction to plastics.

Related Conditions & MeSH terms

• Pharmacodynamic

Intervention

Drug:
• Nalmefene hydrochloride
3mg Nasal spray
• Naloxone hydrochloride
4mg Nasal Spray

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Opiant Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	5 minutes
Secondary	Maximum change in minute ventilation	Maximum change in minute ventilation from opioid induced nadir	90 minutes
Secondary	Time to maximum change in minute ventilation	Time to maximum change in minute ventilation from opioid induced nadir	90 minutes
Secondary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	90 minutes
Secondary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	20 minutes
Secondary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	15 minutes
Secondary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	10 minutes
Secondary	Change in minute ventilation	Change in minute ventilation from opioid induced nadir	2.5 minutes