Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

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.

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