NCT00959816

Brief Summary

The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8

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

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
Last Updated

November 2, 2010

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

August 13, 2009

Last Update Submit

November 1, 2010

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (3)

  • Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)

    One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses

  • ABT-614 levels in cerebral spinal fluid

    0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen

  • ABT-614 levels in blood (plasma)

    0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen

Study Arms (2)

Single Dose (Part 1)

EXPERIMENTAL
Drug: ABT-614

Multiple Dose (Part 2)

EXPERIMENTAL
Drug: ABT-614

Interventions

ABT-614DRUG

Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.

Multiple Dose (Part 2)Single Dose (Part 1)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects between 18 and 40 years of age

You may not qualify if:

  • History of bleeding disorders or deep vein thrombosis (DVT)
  • Previous gastrointestinal (GI) surgery or chronic GI disease
  • History of spinal surgery
  • History of significant, chronic low back pain
  • History of frequent headaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 22445

San Antonio, Texas, 78217, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 17, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Last Updated

November 2, 2010

Record last verified: 2010-09

Locations

US(1)