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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959816
First Posted: August 17, 2009
Last Update Posted: November 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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.

Condition Intervention Phase
Healthy Drug: ABT-614 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 8
Study Start Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Dose (Part 1) Drug: ABT-614
Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.
Experimental: Multiple Dose (Part 2) Drug: ABT-614
Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959816


Locations
United States, Texas
Site Reference ID/Investigator# 22445
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Beatrice Rendenbach-Mueller, PhD / Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00959816     History of Changes
Other Study ID Numbers: M11-954
First Submitted: August 13, 2009
First Posted: August 17, 2009
Last Update Posted: November 2, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Volunteers