A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers

The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.

Inclusion Criteria:

• Age is between 18 and 55 years
• Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

• Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
• Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
• Receipt of any drug depot by injection within 30 days prior to study drug administration.
• Receipt of any investigational product within 6 weeks prior to study drug administration.
• History of significant sensitivity or allergy to any drug.
• History of drug or alcohol abuse.
• Positive test result for HAV, HBsAg, HCV or HIV.
• Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
• Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
• Current enrollment in another clinical study.