A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: iX Biopharma Ltd.
• Collaborator: Jean Brown Research
• Treatments: Ketamine; Oxycodone

Criteria

Inclusion Criteria:

• Scheduled for a bunionectomy (with no additional procedures).

• Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements.

• Body mass index (BMI) ≥19 to ≤33 kg/m2.

• Females: Not pregnant, not lactating, and not planning to become pregnant during the study.

• Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception.

• Able to read and understand English.

• Able to swallow oral capsules whole.

Exclusion Criteria:

• Allergy, intolerance, or contraindication to ketamine, oxycodone, morphine, ibuprofen or surgical medications.

• Clinically significant medical condition.

• History of illicit drug use or alcohol abuse and not in full remission.

• Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.

• Clinically significant 12 lead ECG abnormalities at screening.

• Smokers who are unwilling to abstain during the inpatient stay.