CompletedInterventionalPhase 2Updated Jan 29, 2013
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects | NCT00968422 | Trialant
CompletedInterventionalPhase 1Updated Nov 3, 2010
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
ClinicalTrials.gov ID
NCT00968422
Lead Sponsor
AbbottINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
28Actual
Last Update Posted
Nov 3, 2010Estimated
Start Date
Aug 2009
Primary Completion Date
Jan 2010Actual
Brief Summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
Healthy
ABT-384
Matching placebo to ABT-384
Ages Eligible for Study
Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.