A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-384

• Registration Number: NCT01009216
• Lead Sponsor: Abbott

Brief Summary

The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-12-13
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Age is between 18 and 55 years
• Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria

• Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
• Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
• Receipt of any drug depot by injection within 30 days prior to study drug administration.
• Receipt of any investigational product within 6 weeks prior to study drug administration.
• History of significant sensitivity or allergy to any drug.
• History of drug or alcohol abuse.
• Positive test result for HAV, HBsAg, HCV or HIV.
• Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
• Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
• Current enrollment in another clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-384	ABT-384	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)	Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)	Days 1, 4 through 9

Trial Locations

Locations (1)

Site Reference ID/Investigator# 23882; 🇺🇸 Glendale, California, United States