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OpenTrials
Completed

NCT Number: NCT00912431

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 20761

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-126

Drug

ABT-126 administered on Day 1 of Period 1

Placebo

Drug

Placebo for ABT-126 administered on Day 1 of Period 2

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 3, 2009
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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