A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans

Abbott8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ABT-614DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site Reference ID/Investigator# 22445

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 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

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

ABT-614 levels in blood (plasma)

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

Data from ClinicalTrials.gov

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