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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01009216

First received: October 21, 2009

Last updated: December 13, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 21, 2009
Last Updated Date	December 13, 2010
Start Date ^ICMJE	October 2009
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: November 5, 2009)	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 8 ] [ 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 6 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01009216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid
Official Title ^ICMJE	A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: ABT-384 Doses will be administered daily for 5 days. Other Name: ABT-384
Study Arm (s)	Experimental: ABT-384 Intervention: Drug: ABT-384
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01009216
Other Study ID Numbers ^ICMJE	M10-505
Has Data Monitoring Committee	Not Provided
Responsible Party	Gerard Marek, MD, PhD, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top