Healthy
Conditions
Keywords
Volunteers
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.
Interventions
DRUGABT-614
Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects between 18 and 40 years of age
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed