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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 22445

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-614

Drug

Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
First posted: Aug 17, 2009
Registry last updated: Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed