Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Kansas

Vince and Associates Clinical Research

Overland Park, Kansas, United States, 66212

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Debra Kelsh, MD; Vince & Associates Clinical Research, Inc.

More Information

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT03129347
• Other Study ID Numbers: Nalmefene-Ph1a-001
• First Posted: April 26, 2017
• Last Update Posted: March 26, 2018
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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