Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery

Inclusion Criteria

• Able to provide written informed consent prior to any study procedures;
• Able to communicate clearly with the Investigator and staff;
• Female between 21 and 65 years of age, inclusive;
• Scheduled for elective laparoscopic hysterectomy under general anesthesia;
• Negative result on serum pregnancy test at screening and negative urine pregnancy test at Baseline (for women of child-bearing potential only) and not currently breast feeding, or planning to do so within 30 days of dosing;
• Negative urine drug screen for drugs of abuse at Screening and at Baseline;
• American Society of Anesthesiologists (ASA) risk class of I to III;
• Body mass index (BMI) between 17 and 40 inclusive.

Exclusion Criteria

• Has known allergies to opioids, or hypersensitivity to other materials (such as infusion line) or medications to be used in the study;
• Has a known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-diagnosed alcohol, opiate or other drug abuse or dependence within 12 months prior to screening;
• Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the Treatment Period;
• Is scheduled to undergo a hysterectomy that will utilize any type of robotic technology and/or a concomitant surgical procedure that would produce a significantly greater degree of surgical trauma than the laparoscopic hysterectomy or laparoscopic assisted vaginal hysterectomy alone;
• Has taken non-opioid analgesics (including cyclooxygenase-2 [COX-2] inhibitors) or nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours of the Baseline assessments;
• Has taken any opioid analgesics or used systemic steroids within 4 days of surgery OR has previously used opiates chronically for a period of ≥3 months;
• Has used antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants for 2.5 x the upper limit of normal (ULN) at screening;
• Has bilirubin, blood urea nitrogen (BUN), or creatinine >1.5 x the reference ULN at Screening;
• Has abnormally low hemoglobin 146 mmol/L at Screening;
• Has impaired renal function (creatinine clearance [CrCl] < 50 ml/min) at Screening;
• Has a positive test for human immunodeficiency virus (HIV) or known history of HIV infection;
• Has received another investigational drug within 30 days of scheduled surgery;
• Has a significant chronic pain condition in areas unrelated to the operative site at the time of Screening that in the Investigator's opinion could confound the interpretation of study results