Pharmacokinetic Study of ABT-126 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00959634
First received: August 12, 2009
Last updated: November 2, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: ABT-126
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • ABT-126 levels in blood (plasma) [ Time Frame: First dose through last dose and up to 192 hours after last dose ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959634

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

No publications provided

Responsible Party: Robert Lenz, MD, PhD / Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00959634     History of Changes
Other Study ID Numbers: M11-988
Study First Received: August 12, 2009
Last Updated: November 2, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014