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

November 1, 2010 updated by: Abbott

A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Site Reference ID/Investigator# 20761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-126
ABT-126 administered on Day 1 of Period 1
Placebo Comparator: 2
Drug: Placebo
Placebo for ABT-126 administered on Day 1 of Period 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)
Time Frame: Day 1 thru Day 4 in Periods 1 and 2
Day 1 thru Day 4 in Periods 1 and 2
Pharmacokinetic samples
Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2
Day 1 (up to 24-hour post dose) in Periods 1 and 2
Cerebrospinal Fluid samples
Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2
Day 1 (up to 24-hour post dose) in Periods 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M11-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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