Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

Inclusion criteria

• . Non-smoking males, ages 18-55 years, inclusive, in good general health.
• . Body mass index (BMI) within the range of 18.0 to 34.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
• . Subjects must have completed at least 2 CPTs at Screening (minimum 30 minutes apart or when the dorsal surface hand skin temperature had returned to baseline temperature \[±2°C\]), with both tests resulting in latency time of greater than 20 seconds and less than 120 seconds.
• . Subjects must have had prior therapeutic experience with use of opioids for analgesia without showing signs of opioid-induced vomiting, dysphoria, or clinically significant sedation.
• . Subjects must have agreed to use a double-barrier contraceptive method (condom and spermicide, or condom along with female partner's contraceptive method \[oral, injectable, implanted, transdermal, or intrauterine device (IUD) with or without hormones\]), or at least one partner was confirmed to be surgically sterile, or subject must have agreed to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of study drug. Subjects must have agreed to not donate sperm during the study and for 90 days following the last administration of study drug.
• . Subjects must have been able to speak, read, and understand English sufficiently to allow completion of all study assessments.
• . Subjects must have been able to provide written informed consent.
• . Subjects must have been willing and able to follow study instructions and been likely to complete all study requirements.