A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.

Key facts

Study ID

NCT00968422

Run by

Abbott

People needed

28

Starts

2009-08-01

Last updated by the study team

2010-11-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 23024 — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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