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Clinical Trials/NCT01009216
NCT01009216
Completed
Phase 1

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

Abbott1 site in 1 country12 target enrollmentOctober 2009
ConditionsHealthy
InterventionsABT-384
DrugsABT-384

Overview

Phase
Phase 1
Intervention
ABT-384
Conditions
Healthy
Sponsor
Abbott
Enrollment
12
Locations
1
Primary Endpoint
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
November 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Abbott

Eligibility 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.

Arms & Interventions

ABT-384

Intervention: ABT-384

Outcomes

Primary Outcomes

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

Study Sites (1)

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