NCT00890448

Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate

A Modified Case Control Study to Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.

Detailed description

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.

Conditions

• Toxicity

Interventions

Type	Name	Description
OTHER	Pharmacogenomic whole blood sampling	10 mL, whole blood, one sample on Visit 2

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-04-29
• Last updated: 2012-05-24

Locations

19 sites across 14 countries: United States, Argentina, Canada, Chile, Czechia, Finland, Germany, Latvia, Netherlands, Poland, Russia, Slovakia, South Africa, United Kingdom