A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.
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ClinicalTrials.gov Identifier: NCT00551772 |
Recruitment Status :
Completed
First Posted : October 31, 2007
Last Update Posted : December 25, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: SB-742457 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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. |
Study Start Date : | August 2007 |

- 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 ]
- 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 ]

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Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551772
United States, Indiana | |
GSK Investigational Site | |
Evansville, Indiana, United States, 47714 |
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00551772 |
Other Study ID Numbers: |
AZ3110291 |
First Posted: | October 31, 2007 Key Record Dates |
Last Update Posted: | December 25, 2008 |
Last Verified: | December 2008 |
Bio-availability, healthy elderly volunteers |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |