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Pharmacokinetic Evaluation of Intranasal Nalmefene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04759768
Recruitment Status : Completed
First Posted : February 18, 2021
Last Update Posted : October 22, 2021
Information provided by (Responsible Party):
Opiant Pharmaceuticals Inc

Brief Summary:
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Nalmefene Hydrochloride Drug: Nalmefene Phase 1

Detailed Description:
Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
Actual Study Start Date : February 8, 2021
Actual Primary Completion Date : May 17, 2021
Actual Study Completion Date : May 24, 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: Intramuscular Nalmefene
Nalmefene injection, 1mg, 1 injection
Drug: Nalmefene
1mg intramuscular injection

Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 48 hours ]
    Maximum concentration of plasma nalmefene comparing IN to IM

  2. Time to maximum plasma concentration (Tmax) [ Time Frame: 48 hours ]
    Time to maximum concentration of plasma nalmefene comparing IN to IM

  3. Area under the curve (AUC) [ Time Frame: 48 hours ]
    Area under the curve of plasma nalmefene comparing IN to IM

  4. Half-life (t1/2) [ Time Frame: 48 hours ]
    Half life of plasma nalmefene comparing IN to IM

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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 30 kg/m2, inclusive
  • Adequate venous access
  • Subjects must be non-smokers

Exclusion Criteria:

  • History of clinically significant disease
  • Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
  • 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

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 identifier (NCT number): NCT04759768

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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Opiant Pharmaceuticals Inc
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Principal Investigator: Robert Bass, MD Worldwide Clinical Trials
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Responsible Party: Opiant Pharmaceuticals Inc Identifier: NCT04759768    
Other Study ID Numbers: OPNT003-PK-001
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 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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Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents