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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014