Healthy Volunteers
Conditions
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.
Interventions
DRUGABT-126
Dose administered twice daily on Study Days 1-10
DRUGPlacebo
Dose administered twice daily on Study Days 1-10
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 |
Countries
United States
Outcome results
None listed