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Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers

NCT ID: NCT00912431

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126 and to examine the effects of ABT-126 on exploratory biomarkers after administration of a single does of ABT-126 in healthy volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

ABT-126 administered on Day 1 of Period 1

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for ABT-126 administered on Day 1 of Period 2

Interventions

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ABT-126

ABT-126 administered on Day 1 of Period 1

Intervention Type DRUG

Placebo

Placebo for ABT-126 administered on Day 1 of Period 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects between 18 and 50 years of age

Exclusion Criteria

* History of bleeding disorders or Deep Vein Thrombosis
* History of spinal surgery
* History of migraine headaches, or other types of headaches occuring more than 2 times per month, or history of spinal disc disease, or chronic, significant low back pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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# 20761

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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M11-061

Identifier Type: -

Identifier Source: org_study_id