Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Opioid-Related Disorders

Treatments: Drug: Nalmefene

Study type: Interventional

Funder types: NIH

Identifiers

NCT03129347

Nalmefene-Ph1a-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 4 patient groups

Nalmefene (high dose)

Experimental group

Description:

Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period

Treatment:

Drug: Nalmefene

Nalmefene and Intravail

Experimental group

Description:

Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period

Treatment:

Drug: Nalmefene

Nalmefene (low dose)

Experimental group

Description:

Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period

Treatment:

Drug: Nalmefene

Nalmefene Intramuscular

Experimental group

Description:

Nalmefene intramuscular one time during the 17 day inpatient treatment period

Treatment:

Drug: Nalmefene