The Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine

Exclusion Criteria

• •1. A positive urine test for drugs of abuse or alcohol at screening or prior to the start of dosing.
• •2. Subjects with a clinical history of current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
• •3. Active Psychiatric disease: DSM-IV diagnosis of a current alcohol, opiate, or sedative hypnotic dependence disorder requiring medical detoxification, history of decompensated schizophrenia, schizophreniform, or schizoaffective disorder; Severe mania, hypomania, agitated behaviour, bipolar disorder or post-traumatic stress disorder within the past 90 days; presence of suicidal behavior two years prior to enrolment or suicidal intent within the past 30 days.
• •4. The subject has received an investigational drug or participated in any other research trial within 30 days, 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
• •5. Use of any prescription or non-prescription drugs, vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential CYP2D6 enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study mediation, unless, in the opinion of the Investigator and sponsor, the medication will not interfere with the study procedures or compromise subject safety.
• •6. Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastrointestinal anatomy or motility include gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, intestinal or urinary obstruction, or celiac sprue.
• •7. History of hypersensitivity to amphetamine-type drugs, or history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
• •8. Pregnancy or fertile women without adequate means of contraception.
• •9. Any other medical or psychosocial condition that would preclude useful, safe or consistent participation.