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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00968422
First received: August 28, 2009
Last updated: November 1, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: ABT-384
Drug: Matching placebo to ABT-384
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) [ Time Frame: Days -1 through 27 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Matching placebo to ABT-384
Doses will be administered daily for 21 days

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968422

Locations
United States, Florida
Site Reference ID/Investigator# 23024
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Gerard Marek, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00968422     History of Changes
Other Study ID Numbers: M10-506
Study First Received: August 28, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Pharmacology
Drug Safety
Phase 1 Clinical Trials
Pharmacokinetics

ClinicalTrials.gov processed this record on April 15, 2014