Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) (SAD)

Inclusion Criteria:

1. Males and females, ages 18-50 years (inclusive) in good general health;
2. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive);
3. Minimum weight of 50.0 kg, inclusive;
4. Subjects must have a negative screen for drugs of abuse, cotinine, alcohol, hepatitis B-surface antigen, hepatitis C antibody and antibodies against HIV 1 and 2;
5. Female subjects must have a negative serum pregnancy test at screening and a negative pregnancy test on Day -1;
6. Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm. Acceptable nonbarrier forms of contraception for this study are a nonhormonal intrauterine device (IUD), oral contraceptives and/or spermicide;
7. Male subjects must agree not to donate sperm throughout the study and for 90 days after the last study drug administration;
8. Subjects must have normal or no evidence of clinically significant findings in physical examination and 12-lead electrocardiogram (ECG) according to the Investigator, and normal vital signs (respiratory rate between 10 and 18 breaths per minute, blood pressure between 100-139/50-89 mmHg, heart rate between 40-100 beats per minute, temperature between 96.44°F and 100.04°F (between 35.8°C and 37.8°C), and oxygen saturation (SpO2) > 97% in the absence of supplemental oxygen;
9. Clinical laboratory values must be within the normal limits as defined by the clinical laboratory, unless the Investigator decides that out-of-range values are not clinically significant;
10. Subjects must be able to provide meaningful written informed consent;
11. Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.

Exclusion Criteria:

1. History of allergy or sensitivity to oxycodone, OxyContin, any other opiate, naltrexone, or naloxone;
2. History of loud snoring or sleep apnea;
3. History of medical problems encountered with opioid therapy;
4. Urinary cotinine levels indicative of smoking or history of regular use of tobacco-containing or nicotine-containing products within 2 months prior to screening;
5. History of alcoholism or drug abuse (prescription or illicit drugs) according to Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR) criteria;
6. Use of prescription medications within 14 days of study drug administration, except for contraceptive medications used by female subjects; use of over-the-counter (OTC) medications within 7 days prior to study drug administration;
7. Use of any opioid within 30 days prior to screening;
8. Donation of blood within 60 days prior to screening;
9. Donation of plasma, platelets, or white blood cells within 7 days prior to dosing;
10. Acute illness (eg, gastrointestinal illness, infection such as influenza, upper respiratory tract infection, or known inflammatory process) within 7 days of dosing
11. History of gastrointestinal disturbance requiring frequent use of antacid;
12. History of clinically significant gastrointestinal disease and/or surgery which would result in the subject's inability to absorb or metabolize the study drug (eg, gastrectomy, gastric bypass, cholecystectomy);
13. Anticipated need for surgery or hospitalization during the study or follow-up period;
14. Dosing with an investigational drug or participation in an investigation device study within 30 days or 5 half-lives of first dose of the study drug;
15. Women who are lactating;
16. Any other condition, that, in the Investigator's opinion, (i) puts the subject at increased risk, (ii) could confound the study results (iii) may interfere significantly with the subject's participation in the study or (IV) has the potential to limit the subject's ability to complete the study.