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

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ABT-126

Study type: Interventional

Funder types: Industry

Identifiers

NCT00912431

M11-061

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ABT-126

2

Placebo Comparator group

Treatment:

Drug: Placebo