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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968422

Enrollment

Registered

2009-08-31

Start date

2009-08-31

Completion date

Unknown

Last updated

2010-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacology, Drug Safety, Phase 1 Clinical Trials, Pharmacokinetics

Brief summary

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

Interventions

DRUGABT-384

3 escalating doses will be administered daily for 21 days

DRUGMatching placebo to ABT-384

Doses will be administered daily for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026