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CompletedNCT00959634Updated Nov 3, 2010

Pharmacokinetic Study of ABT-126 in Healthy Volunteers

A Phase 1 interventional study of ABT-126 and Placebo in Healthy Volunteers, sponsored by Abbott. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-03.

Sponsored by Abbott · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    1

    Dose 1 BID

    Drug: ABT-126

  • Experimental
    2

    Dose 2 BID

    Drug: ABT-126

  • Placebo comparator
    3

    Placebo BID

    Drug: Placebo

Interventions

  • DrugABT-126

    Dose administered twice daily on Study Days 1-10

  • DrugPlacebo

    Dose administered twice daily on Study Days 1-10

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)

    Time frame: One day before dosing through day of last dose and up to 6 days after last dose

  2. ABT-126 levels in blood (plasma)

    Time frame: First dose through last dose and up to 192 hours after last dose

07

Study locations

1 site
  • Site Reference ID/Investigator# 22863
    Austin, Texas 78744, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00959634
Lead sponsor
Abbott
First posted
Aug 14, 2009
Start date
Aug 2009
Primary completion
Sep 2009
Last update
Nov 3, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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