Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00968422
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : November 3, 2010
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ABT-384 Drug: Matching placebo to ABT-384 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : January 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) [ Time Frame: Days -1 through 27 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968422


Locations
Layout table for location information
United States, Florida
Site Reference ID/Investigator# 23024
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Abbott

Layout table for additonal information
Responsible Party: Gerard Marek, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00968422     History of Changes
Other Study ID Numbers: M10-506
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: September 2010
Keywords provided by Abbott:
Pharmacology
Drug Safety
Phase 1 Clinical Trials
Pharmacokinetics