Pharmacodynamic Evaluation of Intranasal Nalmefene

Sponsor

Opiant Pharmaceuticals Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04828005

Collaborator

(none)

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacodynamic	Drug: Nalmefene hydrochloride Drug: Naloxone hydrochloride	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 30, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal Nalmefene Nalmefene hydrochloride nasal spray, 3mg, 1 spray	Drug: Nalmefene hydrochloride 3mg Nasal spray
Active Comparator: Intranasal Naloxone Naloxone hydrochloride nasal spray, 4mg, 1 spray	Drug: Naloxone hydrochloride 4mg Nasal Spray

Arm

Intervention/Treatment

Experimental: Intranasal Nalmefene

Nalmefene hydrochloride nasal spray, 3mg, 1 spray

Drug: Nalmefene hydrochloride

3mg Nasal spray

Active Comparator: Intranasal Naloxone

Naloxone hydrochloride nasal spray, 4mg, 1 spray

Drug: Naloxone hydrochloride

4mg Nasal Spray

Outcome Measures

Primary Outcome Measures

Change in minute ventilation [5 minutes]
Change in minute ventilation from opioid induced nadir

Secondary Outcome Measures

Maximum change in minute ventilation [90 minutes]
Maximum change in minute ventilation from opioid induced nadir
Time to maximum change in minute ventilation [90 minutes]
Time to maximum change in minute ventilation from opioid induced nadir
Change in minute ventilation [90 minutes]
Change in minute ventilation from opioid induced nadir
Change in minute ventilation [20 minutes]
Change in minute ventilation from opioid induced nadir
Change in minute ventilation [15 minutes]
Change in minute ventilation from opioid induced nadir
Change in minute ventilation [10 minutes]
Change in minute ventilation from opioid induced nadir
Change in minute ventilation [2.5 minutes]
Change in minute ventilation from opioid induced nadir

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Opiant Pharmaceuticals Inc

Investigators

Principal Investigator: Shawn Searle, MD, PRA Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Opiant Pharmaceuticals Inc

ClinicalTrials.gov Identifier:

NCT04828005

Other Study ID Numbers:

OPNT003-PD-001

First Posted:

Apr 1, 2021

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Naloxone

Nalmefene

Study Results

No Results Posted as of Oct 22, 2021