Evaluation of Oral PF614 Relative to OxyContin

Inclusion Criteria:

• Males or females, ages 18-50 years in good general health,
• BMI between 18 and 32 kg/m (inclusive)
• Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, Hepatitis B, Hepatitis C, and HIV.
• Female subjects of child bearing potential must have a negative serum pregnancy test at randomization
• Females must be of non-child bearing potential (e.g. postmenopausal) or of childbearing potential and agree to use a highly effective form of contraception from the time of screening to two weeks after last dose of study medication.
• Subjects must have normal findings in a physical examination and 12 lead ECG and normal Vital Signs
• Clinical laboratory values must be Within Normal limits as defined by the clinical laboratory
• Subjects must be able to provide coherent written informed consent
• Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.

Exclusion Criteria:

• History of allergy or sensitivity to oxycodone
• History of loud snoring or sleep apnea
• History of medical problems encountered with opioid therapy
• Urinary cotinine levels indicative of smoking or history of smoking or regular tobacco use with 2 months prior to screening
• History of alcoholism or drug abuse
• Use of prescription medications within 14 days of study drug administration with exception of contraceptives used by female subjects
• Use of any opioid within 30 days prior to screening
• History of allergy or sensitivity to naltrexone
• History of allergy or sensitivity to naloxone
• Donation of blood within 30 days prior to screening
• Donation of plasma within 30 days prior to screening
• Acute illness at admission of clinical study unit
• History of GI disturbance requiring use of antacid twice weekly or more
• Females who are breastfeeding
• Anticipated need for surgery or hospitalization during the study
• Enrollment in an investigational drug study within 30 days prior to screening
• Any condition that in the Investigator's opinion puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.