NCT00912431

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

November 2, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

June 2, 2009

Last Update Submit

November 1, 2010

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: ABT-126

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ABT-126DRUG

ABT-126 administered on Day 1 of Period 1

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects between 18 and 50 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 20761

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

ABT-126

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Last Updated

November 2, 2010

Record last verified: 2010-09

Locations

US(1)