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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00912431
First received: June 2, 2009
Last updated: November 1, 2010
Last verified: September 2010

June 2, 2009
November 1, 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic samples [ Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2 ] [ Designated as safety issue: No ]
  • Cerebrospinal Fluid samples [ Time Frame: Day 1 (up to 24-hour post dose) in Periods 1 and 2 ] [ Designated as safety issue: No ]
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 Blind (Subject)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Not Provided
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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00912431
M11-061
Not Provided
Daniel Llano, MD, PhD/Associate Medical Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
September 2010

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