NCT00968422

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

November 3, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

August 28, 2009

Last Update Submit

November 1, 2010

Conditions

Healthy

Keywords

PharmacologyDrug SafetyPhase 1 Clinical TrialsPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Low dose ABT-384

EXPERIMENTAL
Drug: ABT-384

Mid dose ABT-384

EXPERIMENTAL
Drug: ABT-384

High dose ABT-384

EXPERIMENTAL
Drug: ABT-384

Placebo

PLACEBO COMPARATOR
Drug: Matching placebo to ABT-384

Interventions

ABT-384DRUG

3 escalating doses will be administered daily for 21 days

High dose ABT-384Low dose ABT-384Mid dose ABT-384
Matching placebo to ABT-384DRUG

Doses will be administered daily for 21 days

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age is 65 years or greater
  • 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

You may not qualify if:

  • Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
  • Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
  • Receipt of any drug depot by injection within 30 days prior to study drug administration.
  • Receipt of any investigational product within 6 weeks prior to study drug administration.
  • History of significant sensitivity or allergy to any drug.
  • History of drug or alcohol abuse within 2 years.
  • Positive test result for HBV, HCV or HIV.
  • Estimated creatinine clearance \< 30 mL/min.
  • 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.
  • Current enrollment in another clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 23024

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

N-(5-(aminocarbonyl)tricyclo(3.3.1.13,7)dec-2-yl)-alpha,alpha-dimethyl-4-(5-(trifluoromethyl)-2-pyridinyl)-1-piperazineacetamide

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Last Updated

November 3, 2010

Record last verified: 2010-09

Locations

US(1)