Pharmacokinetic Study of ABT-126 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABT-126; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)	One day before dosing through day of last dose and up to 6 days after last dose
ABT-126 levels in blood (plasma)	First dose through last dose and up to 192 hours after last dose

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (Estimate): August 14, 2009

Study Record Updates

• Last Update Posted (Estimate): November 3, 2010
• Last Update Submitted That Met QC Criteria: November 2, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: M11-988