Status:
COMPLETED
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
Lead Sponsor:
Abbott
Conditions:
Healthy
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00968422
Start Date
August 1 2009
Last Update
November 3 2010
Active Locations (1)
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1
Site Reference ID/Investigator# 23024
Orlando, Florida, United States, 32809