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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014