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

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ClinicalTrials.gov Identifier: NCT00912431
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ABT-126 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects
Study Start Date : June 2009
Actual Primary Completion Date : August 2009
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetic samples [ Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2 ]
  3. Cerebrospinal Fluid samples [ Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912431


Locations
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United States, California
Site Reference ID/Investigator# 20761
Glendale, California, United States, 91206
Sponsors and Collaborators
Abbott
More Information
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Responsible Party: Daniel Llano, MD, PhD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00912431    
Other Study ID Numbers: M11-061
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: September 2010
Keywords provided by Abbott:
Healthy Volunteers