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

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-614

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959816

M11-954

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Single Dose (Part 1)

Experimental group

Treatment:

Drug: ABT-614

Multiple Dose (Part 2)

Experimental group

Treatment:

Drug: ABT-614