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Pharmacodynamic Evaluation of Intranasal Nalmefene

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ClinicalTrials.gov Identifier: NCT04828005
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Opiant Pharmaceuticals Inc

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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 : March 30, 2021
Estimated Primary Completion Date : October 20, 2021
Estimated Study Completion Date : October 20, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in minute ventilation [ Time Frame: 5 minutes ]
    Change in minute ventilation from opioid induced nadir


Secondary Outcome Measures :
  1. Maximum change in minute ventilation [ Time Frame: 90 minutes ]
    Maximum change in minute ventilation from opioid induced nadir

  2. Time to maximum change in minute ventilation [ Time Frame: 90 minutes ]
    Time to maximum change in minute ventilation from opioid induced nadir

  3. Change in minute ventilation [ Time Frame: 90 minutes ]
    Change in minute ventilation from opioid induced nadir

  4. Change in minute ventilation [ Time Frame: 20 minutes ]
    Change in minute ventilation from opioid induced nadir

  5. Change in minute ventilation [ Time Frame: 15 minutes ]
    Change in minute ventilation from opioid induced nadir

  6. Change in minute ventilation [ Time Frame: 10 minutes ]
    Change in minute ventilation from opioid induced nadir

  7. Change in minute ventilation [ Time Frame: 2.5 minutes ]
    Change in minute ventilation from opioid induced nadir



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828005


Contacts
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Contact: PRA Health Sciences 8018212156 info@opiant.com

Locations
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United States, Utah
PRA Health Sciences Recruiting
Salt Lake City, Utah, United States, 84124
Contact: PRA-EDS    801-821-2156      
Sponsors and Collaborators
Opiant Pharmaceuticals Inc
Investigators
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Principal Investigator: Shawn Searle, MD PRA Health Sciences
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Responsible Party: Opiant Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT04828005    
Other Study ID Numbers: OPNT003-PD-001
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Naloxone
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents