GSK2647544 RD, DDI study in healthy young and elderly volunteers
Research type
Research Study
Full title
Single-blind, randomised, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat doses of GSK2647544 and its potential pharmacokinetic interaction with simvastatin in healthy volunteers
IRAS ID
139023
Contact name
Annelize Koch
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2013-003339-31
ISRCTN Number
not provided
Research summary
The new medicine tested in this study is called GSK2647544. GSK is developing the study drug for treating Alzheimer’s disease. The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised, distributed through the body and excreted. A further aim is to look at whether the study drug affects the way the body is handling another drug called simvastatin.
The study will be performed at the PAREXEL Early Phase Clinical Unit in the UK (Harrow).
Healthy, young (18 to 64 years of age [inclusive]) males and females (Cohort 1, 2 and 3) and elderly (≥ 65 years of age) males and females (Cohort 4) will be included in this clinical study.
Forty-eight (48) participants will take part in the study. Cohort 1 and 3 will each consist of 12 participants while Cohort 2 consists of 8 participants. Cohort 4 will consist of 16 participants. Cohort 4 will be further divided into two groups containing 4 or 12 participants per group.
Participants will receive simvastatin, GSK2647544 or a placebo in the form of tablets or capsules which they will swallow with a glass of water. The ratio in each cohort for the GSK2647544 to placebo is 3:1.
The following processes will be performed and information collected: demographic data and medical history; height and weight; screening for drugs-of-abuse, alcohol and cotinine; vital signs; physical examinations, electrocardiograms; different kinds of urine and blood safety tests; blood and urine samples will be taken for measurement of the concentration of GSK2647544 and for metabolic profiling; assessments of suicidality; a blood sample for DNA analysis may be taken and any adverse events that the participants experience and other medications that they take, will be recorded.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1451
Date of REC Opinion
21 Nov 2013
REC opinion
Further Information Favourable Opinion