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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01009216

Run by

Abbott

People needed

12

Starts

2009-10-01

Expected to finish

2010-11-01

Last updated by the study team

2010-12-14

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 23882 — Glendale, California, United States

Full record on ClinicalTrials.gov

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