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 Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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