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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00912431
Enrollment
10
Registered
2009-06-03
Start date
2009-06-30
Completion date
Unknown
Last updated
2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers

Brief summary

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.

Interventions

DRUGABT-126

ABT-126 administered on Day 1 of Period 1

DRUGPlacebo

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

Sponsors

Abbott
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)Day 1 thru Day 4 in Periods 1 and 2
Pharmacokinetic samplesDay 1 (up to 24-hour post dose) in Periods 1 and 2
Cerebrospinal Fluid samplesDay 1 (up to 24-hour post dose) in Periods 1 and 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026