Trial record 2 of 5 for:    SB-742457

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00551772
First received: October 29, 2007
Last updated: December 23, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: SB-742457
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomised, Two-Part Crossover Study to Assess the Pharmacokinetics of a Single Dose of SB-742457 Formulated as a Capsule and a Tablet in Healthy Elderly Volunteers.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To characterise pharmacokinetics ( AUC(0-inf) and Cmax ) of SB-742457 from pre-dose to 96 hours following single doses formulated as a capsule and a tablet. [ Time Frame: pre-dose to 96 hours ]

Secondary Outcome Measures:
  • To assess safety and tolerability (adverse events, blood pressure, heart rate, 12-lead ECG, blood haematology/clinical chemistry and urinalysis) of SB-742457 following single doses formulated as a capsule and a tablet over the 6 week study period. [ Time Frame: 6 week study period ]

Estimated Enrollment: 12
Study Start Date: August 2007
Intervention Details:
    Drug: SB-742457
    Other Name: SB-742457
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Men or surgically sterile or post-menopausal women
  • Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or lab evaluation.
  • BMI between 18.5 and 32.0 kg/m2

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 days prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Where participation in the study would result in donation of blood in excess of 500ml within a 56 day period.
  • Has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • The subject has received an investigational drug or participated in another research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • Known or suspected history of seizures, including febrile seizures, unexplained recent loss of consciousness or history of significant head trauma with loss of consciousness.
  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: NCT00551772

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00551772     History of Changes
Other Study ID Numbers: AZ3110291
Study First Received: October 29, 2007
Last Updated: December 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Bio-availability, healthy elderly volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014