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

NCT ID: NCT00959816

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Dose (Part 1)

Group Type EXPERIMENTAL

ABT-614

Intervention Type DRUG

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

Multiple Dose (Part 2)

Group Type EXPERIMENTAL

ABT-614

Intervention Type DRUG

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

Interventions

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ABT-614

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 22445

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M11-954

Identifier Type: -

Identifier Source: org_study_id