Pharmacokinetic Study of ABT-126 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959634
• Other study ID #: M11-988
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2009
• Last updated: November 2, 2010
• Start date: August 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABT-126
Dose administered twice daily on Study Days 1-10
• Placebo
Dose administered twice daily on Study Days 1-10

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 22863	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	ABT-126 levels in blood (plasma)		First dose through last dose and up to 192 hours after last dose	No