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
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, see Learn About Clinical Studies.

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 October 23, 2014