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

November 1, 2010 updated by: Abbott
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Site Reference ID/Investigator# 23024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Matching placebo to ABT-384
Doses will be administered daily for 21 days
Experimental: Low dose ABT-384
Drug: ABT-384
3 escalating doses will be administered daily for 21 days
Experimental: Mid dose ABT-384
Drug: ABT-384
3 escalating doses will be administered daily for 21 days
Experimental: High dose ABT-384
Drug: ABT-384
3 escalating doses will be administered daily for 21 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M10-506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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