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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-384; Drug: Matching placebo to ABT-384

• Registration Number: NCT00968422
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Primary Completion: 2010-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Age is 65 years or greater
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

1. Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose ABT-384	ABT-384	-
Mid dose ABT-384	ABT-384	-
High dose ABT-384	ABT-384	-
Placebo	Matching placebo to ABT-384	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)	Days -2 through 84
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)	Days -1 through 27

Trial Locations

Locations (1)

Site Reference ID/Investigator# 23024; 🇺🇸 Orlando, Florida, United States