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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014