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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

June 2, 2009
June 3, 2009
November 2, 2010
June 2009
August 2009   (Final data collection date for primary outcome measure)
  • 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 ]
  • Pharmacokinetic samples [ Time Frame: 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 ]
Same as current
Complete list of historical versions of study NCT00912431 on ClinicalTrials.gov Archive Site
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Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Healthy
  • Drug: ABT-126
    ABT-126 administered on Day 1 of Period 1
  • Drug: Placebo
    Placebo for ABT-126 administered on Day 1 of Period 2
  • Experimental: 1
    Intervention: Drug: ABT-126
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
8
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August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00912431
M11-061
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Daniel Llano, MD, PhD/Associate Medical Director, Abbott
Abbott
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Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP