Pharmacokinetic Study of ABT-126 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959634
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : November 3, 2010
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ABT-126 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
Dose 1 BID
Drug: ABT-126
Dose administered twice daily on Study Days 1-10

Experimental: 2
Dose 2 BID
Drug: ABT-126
Dose administered twice daily on Study Days 1-10

Placebo Comparator: 3
Placebo BID
Drug: Placebo
Dose administered twice daily on Study Days 1-10

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959634

United States, Texas
Site Reference ID/Investigator# 22863
Austin, Texas, United States, 78744
Sponsors and Collaborators

Responsible Party: Robert Lenz, MD, PhD / Project Director, Abbott Identifier: NCT00959634     History of Changes
Other Study ID Numbers: M11-988
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: September 2010