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
  Purpose

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 Intervention Phase
Healthy
Drug: ABT-126
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: June 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912431

Locations
United States, California
Site Reference ID/Investigator# 20761
Glendale, California, United States, 91206
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Daniel Llano, MD, PhD/Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00912431     History of Changes
Other Study ID Numbers: M11-061
Study First Received: June 2, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Healthy Volunteers

ClinicalTrials.gov processed this record on April 15, 2014