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

August 13, 2009
November 1, 2010
August 2009
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00959816 on ClinicalTrials.gov Archive Site
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A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
  • Experimental: Single Dose (Part 1)
    Intervention: Drug: ABT-614
  • Experimental: Multiple Dose (Part 2)
    Intervention: Drug: ABT-614
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
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August 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959816
M11-954
No
Beatrice Rendenbach-Mueller, PhD / Project Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP