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Pharmacokinetic Study of ABT-126 in Healthy Volunteers

NCT ID: NCT00959634

Last Updated: 2010-11-03

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Dose 1 BID

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

Dose administered twice daily on Study Days 1-10

2

Dose 2 BID

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

Dose administered twice daily on Study Days 1-10

3

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose administered twice daily on Study Days 1-10

Interventions

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ABT-126

Dose administered twice daily on Study Days 1-10

Intervention Type DRUG

Placebo

Dose administered twice daily on Study Days 1-10

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between 18 and 50 years of age
* If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
* If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

Exclusion Criteria

* Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
* Presence of any uncontrolled medical illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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# 22863

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M11-988

Identifier Type: -

Identifier Source: org_study_id