Last updated: 11/04/2018 05:24:25
A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.
GSK study ID
AZ3110291
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: pre-dose to 96 hours
Secondary outcomes:
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.
Timeframe: 6 week study period
Interventions:
Drug: SB-742457
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
SB742457
Collaborators
Not applicable
Study date(s)
August 2007 to September 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
60 - 85 Years
Accepts healthy volunteers
yes
- 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.
- A positive pre-study urine screen for drugs of abuse
- Abuse of alcohol
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-21-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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