A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.

Last updated: December 23, 2008
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

1

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00551772
AZ3110291
  • Ages 60-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

SB-742457 is a 5HT6 receptor antagonist that is in development for the symptomatic treatment of mild to moderate Alzheimer's disease . To date, all clinical trials have been conducted using a capsule formulation of SB-742457. However, it is intended to conduct all futures studies with a tablet formulation. The aim of this study is to assess the pharmacokinetic profile of SB-742457 and its major metabolites following single doses of both the capsule and tablet formulations.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Men or surgically sterile or post-menopausal women

  • Healthy as judged by a responsible physician. No clinically significant abnormalityidentified on the medical or lab evaluation.

  • BMI between 18.5 and 32.0 kg/m2

Exclusion

Exclusion criteria:

  • A positive pre-study urine screen for drugs of abuse

  • Abuse of alcohol

  • Subjects who smoke more than 10 cigarettes or equivalent a day.

  • Use of prescription drugs as well as herbal and dietary supplements within 7 daysprior to the first dose of study medication, unless in the opinion of the Investigatorand sponsor the medication will not interfere with the study procedures or compromisesubject safety.

  • Where participation in the study would result in donation of blood in excess of 500mlwithin a 56 day period.

  • Has a history or presence of gastro-intestinal, hepatic or renal disease or othercondition known to interfere with the absorption, distribution, metabolism orexcretion of drugs.

  • The subject has received an investigational drug or participated in another researchtrial within 30 days or 5 half-lives, or twice the duration of the biological effectof any drug (whichever is longer) prior to the first dose of current study medication.

  • Known or suspected history of seizures, including febrile seizures, unexplained recentloss of consciousness or history of significant head trauma with loss ofconsciousness.

Study Design

Total Participants: 12
Study Start date:
August 01, 2007
Estimated Completion Date:

Connect with a study center

  • GSK Investigational Site

    Evansville, Indiana 47714
    United States

    Site Not Available

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