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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01009216
First received: October 21, 2009
Last updated: December 13, 2010
Last verified: November 2010
  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: 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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.
Other Name: ABT-384

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009216

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

No publications provided

Responsible Party: Gerard Marek, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT01009216     History of Changes
Other Study ID Numbers: M10-505
Study First Received: October 21, 2009
Last Updated: December 13, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014