Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

Inclusion Criteria:

- Males and females 18 to 55 years of age, inclusive.

- Provide written informed consent.

- BMI ranging from 18 to 30 kg/m2, inclusive.

- Adequate venous access.

- No clinically significant concurrent medical conditions determined by medical
history, physical examination, clinical laboratory examination, vital signs, and
12-lead ECG.

- Male subjects must agree to use an acceptable method 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 subject of childbearing potential must
agree to use an acceptable method of birth control throughout the study and for 30
days after the last study drug administration. Oral contraceptives are prohibited.

- Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca
Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice.

- Participate in strenuous exercise 72 hours prior to admission through the last blood
draw of the study.

Exclusion Criteria:

- Please contact site for more information