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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

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.
Other Name: ABT-614
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.
Other Name: ABT-614

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959816

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

No publications provided

Responsible Party: Beatrice Rendenbach-Mueller, PhD / Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00959816     History of Changes
Other Study ID Numbers: M11-954
Study First Received: August 13, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Volunteers

ClinicalTrials.gov processed this record on April 15, 2014