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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-614

• Registration Number: NCT00959816
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Dose (Part 1)	ABT-614	-
Multiple Dose (Part 2)	ABT-614	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)	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	0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
ABT-614 levels in blood (plasma)	0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen

Trial Locations

Locations (1)

Site Reference ID/Investigator# 22445; 🇺🇸 San Antonio, Texas, United States