Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

NCT03129347 | Completed Phase 1 FDA Drug

• 1 other identifier: Nalmefene-Ph1a-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of nalmefene

  Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve

  17 days

Secondary Outcomes (1)

• Safety and tolerability

  17 days

Study Arms (4)

Nalmefene (high dose)

EXPERIMENTAL

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

Drug: Nalmefene

Nalmefene and Intravail

EXPERIMENTAL

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

Drug: Nalmefene

Nalmefene (low dose)

EXPERIMENTAL

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

Drug: Nalmefene

Nalmefene Intramuscular

EXPERIMENTAL

Nalmefene intramuscular one time during the 17 day inpatient treatment period

Drug: Nalmefene

Interventions

Nalmefene DRUG

Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene

Also known as: Selincro

Nalmefene (high dose); Nalmefene (low dose); Nalmefene Intramuscular; Nalmefene and Intravail

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Please contact the site for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Debra Kelsh, MD

  Vince & Associates Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: June 1, 2017
• Primary Completion: June 9, 2017
• Study Completion: July 3, 2017
• Last Updated: March 26, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)