OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Healthy volunteer age between 20 and 40 years.

• Healthy according to medical history and physical examination.

• Informed consent given.

• Phenotyped or genotyped as extensive or poor metabolizer of sparteine.

• Female: Use of safe contraception (IUD, gestagen injectiones or oral contraceptive) or negative u-HCG test.

Exclusion Criteria:

• Any known allergy or intolerance to oxycodone.

• Regularly drug therapy or medication (except contraceptives).

• Alcohol or medicine abuse.