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Completed

NCT Number: NCT01009216

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 23882

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-384

Drug

Doses will be administered daily for 5 days.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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