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

A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ABT-384

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Site Reference ID/Investigator# 23882

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-384	Drug: ABT-384; Doses will be administered daily for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacology; Drug Safety; Phase 1 Clinical Trials
• Other Study ID Numbers: M10-505