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Trial record 1 of 1 for:    NCT03129347
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Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03129347
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Brief Summary:
This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Nalmefene Phase 1

Detailed Description:
This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 9, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nalmefene (high dose)
Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period
Drug: Nalmefene
Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
Other Name: Selincro

Experimental: Nalmefene and Intravail
Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period
Drug: Nalmefene
Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
Other Name: Selincro

Experimental: Nalmefene (low dose)
Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period
Drug: Nalmefene
Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
Other Name: Selincro

Experimental: Nalmefene Intramuscular
Nalmefene intramuscular one time during the 17 day inpatient treatment period
Drug: Nalmefene
Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
Other Name: Selincro




Primary Outcome Measures :
  1. Pharmacokinetic parameters of nalmefene [ Time Frame: 17 days ]
    Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve


Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 17 days ]
    Measure by adverse events, vital signs, ECG, clinical laboratory changes and nasal irritation following the administration of nalmefene



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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:

  • Males and females 18 to 55 years of age
  • Provide written informed consent
  • Body Mass index (BMI) ranging from 18 to 32 kg/m2
  • Adequate venous access
  • No clinically significant concurrent medical conditions
  • Males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration
  • Female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
  • Agree not to ingest alcohol, drinks containing xanthine >500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

  • Please contact the site for more information

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): NCT03129347


Locations
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United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Debra Kelsh, MD Vince & Associates Clinical Research, Inc.
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03129347    
Other Study ID Numbers: Nalmefene-Ph1a-001
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: November 2017
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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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents