Pharmacokinetic Study of ABT-126 in Healthy Volunteers
- Registration Number
- NCT00959634
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ABT-126 Dose 1 BID 2 ABT-126 Dose 2 BID 3 Placebo Placebo BID
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 22863
🇺🇸Austin, Texas, United States