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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-126; Drug: Placebo

• Registration Number: NCT00912431
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2009-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	ABT-126	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 samples	Day 1 (up to 24-hour post dose) in Periods 1 and 2
Cerebrospinal Fluid samples	Day 1 (up to 24-hour post dose) in Periods 1 and 2

Trial Locations

Locations (1)

Site Reference ID/Investigator# 20761; 🇺🇸 Glendale, California, United States