Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg

This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.

Key Inclusion criteria:

1. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
2. Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range [18.0-30.0] kg/m2 (inclusive).
3. Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions.

Key Exclusion criteria:

1. Females who are pregnant or lactating.
2. Current or recent (within 5 years) history of drug or alcohol abuse.
3. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
4. Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride.
5. Dosing in a clinical drug study during the 30 days preceding the initial dose in this study.
6. Any significant illness during the 30 days preceding the initial dose in this study

Other inclusion/exclusion criteria may apply.