A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
NCT ID: NCT00968422
Last Updated: 2010-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose ABT-384
ABT-384
3 escalating doses will be administered daily for 21 days
Mid dose ABT-384
ABT-384
3 escalating doses will be administered daily for 21 days
High dose ABT-384
ABT-384
3 escalating doses will be administered daily for 21 days
Placebo
Matching placebo to ABT-384
Doses will be administered daily for 21 days
Interventions
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ABT-384
3 escalating doses will be administered daily for 21 days
Matching placebo to ABT-384
Doses will be administered daily for 21 days
Eligibility Criteria
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Inclusion Criteria
2. 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
2. Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
3. Receipt of any drug depot by injection within 30 days prior to study drug administration.
4. Receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of significant sensitivity or allergy to any drug.
6. History of drug or alcohol abuse within 2 years.
7. Positive test result for HBV, HCV or HIV.
8. Estimated creatinine clearance \< 30 mL/min.
9. 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.
10. Current enrollment in another clinical study.
65 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Site Reference ID/Investigator# 23024
Orlando, Florida, United States
Countries
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Other Identifiers
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M10-506
Identifier Type: -
Identifier Source: org_study_id