Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.
|Study Design:||Observational Model: Case Control|
|Official Title:||A Modified Case Control Study to Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate|
- Whole genome scanning using the Illumina 1M chip. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
- Whole genome scanning using the Affymetrix 500K array chip. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
- Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Pharmacogenomic whole blood sample
|Study Start Date:||May 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
|Lapaquistat acetate participants||
Other: Pharmacogenomic whole blood sampling
10 mL, whole blood, one sample on Visit 2
Other Name: TAK-475
This is a modified case control study to investigate the association of genotype with phenotype in subjects who experienced alanine aminotransferase and bilirubin derangements following exposure to lapaquistat acetate.
The DNA profile of subjects who experienced significant biochemical hepatic derangement following exposure to lapaquistat acetate (cases) will be compared with a population of pre-genotyped untreated individuals (controls) from a public database. The DNA from subjects who had hepatic derangement during lapaquistat acetate studies, in the absence of exposure to lapaquistat acetate, will be stored. If data from the subjects exposed to lapaquistat acetate indicates that there is a genetic marker of interest, the stored DNA from non-exposed subjects will be assayed to further investigate the signal. One 10 mL sample of whole blood will be collected in plastic K2EDTA tube, after informed consent has been obtained.
Each subject will sign the informed consent document prior to undergoing the study-related procedure. One 10 mL sample of whole blood will be collected from each subject. Extracted DNA will be analyzed using a whole genome scan approach as well as a candidate gene approach.
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|Study Director:||Medical Director||Takeda Global Research & Development Centre (Europe) Ltd.|