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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01009216
First Posted: November 6, 2009
Last Update Posted: December 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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.

Condition Intervention Phase
Healthy Drug: ABT-384 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers

Further study details as provided by Abbott:

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

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-384 Drug: ABT-384
Doses will be administered daily for 5 days.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009216


Locations
United States, California
Site Reference ID/Investigator# 23882
Glendale, California, United States, 91206
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Gerard Marek, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT01009216     History of Changes
Other Study ID Numbers: M10-505
First Submitted: October 21, 2009
First Posted: November 6, 2009
Last Update Posted: December 14, 2010
Last Verified: November 2010

Keywords provided by Abbott:
Pharmacokinetics
Pharmacology
Drug Safety
Phase 1 Clinical Trials