A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid
This study has been completed.
Information provided by:
First received: October 21, 2009
Last updated: December 13, 2010
Last verified: November 2010
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers|
Further study details as provided by Abbott:
Primary Outcome Measures:
- Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) [ Time Frame: Days -1 through 9 ] [ Designated as safety issue: Yes ]
- Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) [ Time Frame: Days 1, 4 through 9 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Doses will be administered daily for 5 days.
Other Name: ABT-384
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