NCT00968422
Completed
Phase 1
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- ABT-384
- Conditions
- Healthy
- Sponsor
- Abbott
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age is 65 years or greater
- •Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Exclusion Criteria
- •Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
- •Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
- •Receipt of any drug depot by injection within 30 days prior to study drug administration.
- •Receipt of any investigational product within 6 weeks prior to study drug administration.
- •History of significant sensitivity or allergy to any drug.
- •History of drug or alcohol abuse within 2 years.
- •Positive test result for HBV, HCV or HIV.
- •Estimated creatinine clearance \< 30 mL/min.
- •Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
- •Current enrollment in another clinical study.
Arms & Interventions
Low dose ABT-384
Intervention: ABT-384
Mid dose ABT-384
Intervention: ABT-384
High dose ABT-384
Intervention: ABT-384
Placebo
Intervention: Matching placebo to ABT-384
Outcomes
Primary Outcomes
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time Frame: Days -2 through 84
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
Time Frame: Days -1 through 27
Study Sites (1)
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