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

Abbott logo

Abbott

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Matching placebo to ABT-384
Drug: ABT-384

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968422
M10-506

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 4 patient groups, including a placebo group

Low dose ABT-384
Experimental group
Treatment:
Drug: ABT-384
Mid dose ABT-384
Experimental group
Treatment:
Drug: ABT-384
High dose ABT-384
Experimental group
Treatment:
Drug: ABT-384
Placebo
Placebo Comparator group
Treatment:
Drug: Matching placebo to ABT-384

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems