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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009216

Enrollment

Registered

2009-11-06

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Pharmacology, Drug Safety, Phase 1 Clinical Trials

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.

Interventions

DRUGABT-384

Doses will be administered daily for 5 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)	Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)	Days 1, 4 through 9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026