A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00959816

First received: August 13, 2009

Last updated: November 1, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 13, 2009
Last Updated Date	November 1, 2010
Start Date ^ICMJE	August 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 14, 2009)	Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination) [ Time Frame: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses ] [ Designated as safety issue: Yes ] ABT-614 levels in cerebral spinal fluid [ Time Frame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen ] [ Designated as safety issue: No ] ABT-614 levels in blood (plasma) [ Time Frame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00959816 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 to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
Official Title ^ICMJE	Not Provided
Brief Summary	The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: ABT-614 Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2. Other Name: ABT-614
Study Arm (s)	Experimental: Single Dose (Part 1) Intervention: Drug: ABT-614 Experimental: Multiple Dose (Part 2) Intervention: Drug: ABT-614
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	8
Completion Date	Not Provided
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy male subjects between 18 and 40 years of age Exclusion Criteria: History of bleeding disorders or deep vein thrombosis (DVT) Previous gastrointestinal (GI) surgery or chronic GI disease History of spinal surgery History of significant, chronic low back pain History of frequent headaches
Gender	Male
Ages	18 Years to 40 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	NCT00959816
Other Study ID Numbers ^ICMJE	M11-954
Has Data Monitoring Committee	No
Responsible Party	Beatrice Rendenbach-Mueller, PhD / Project Director, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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