Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Completed · Phase 1

Conditions studied: Opioid-Related Disorders

In brief

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

Key facts

Study ID

NCT03129347

Run by

National Institute on Drug Abuse (NIDA)

People needed

14

Starts

2017-06-01

Expected to finish

2017-07-03

Last updated by the study team

2018-03-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Vince and Associates Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.