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
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, see Learn About Clinical Studies.

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 September 30, 2014