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

NCT ID: NCT01009216

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics Pharmacology Drug Safety Phase 1 Clinical Trials

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-384

Group Type EXPERIMENTAL

ABT-384

Intervention Type DRUG

Doses will be administered daily for 5 days.

Interventions

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ABT-384

Doses will be administered daily for 5 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 23882

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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M10-505

Identifier Type: -

Identifier Source: org_study_id