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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00890448

Enrollment

Registered

2009-04-29

Start date

2009-05-31

Completion date

2010-05-31

Last updated

2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toxicity

Keywords

Alanine Transaminase elevation, Genetic Markers, DNA Markers

Brief 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.

Interventions

OTHERPharmacogenomic whole blood sampling

10 mL, whole blood, one sample on Visit 2

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Has experienced an alanine aminotransferase level greater than or equal to 5 times the upper limit of normal, or concurrent elevation of alanine aminotransferase greater than or equal to 3 times the upper limit of normal and bilirubin greater than or equal to 2 times the upper limit of normal while participating in lapaquistat acetate clinical studies.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Whole genome scanning using the Illumina 1M chip.	Visit 2
Whole genome scanning using the Affymetrix 500K array chip.	Visit 2
Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array.	Visit 2

Countries

Argentina, Canada, Chile, Czechia, Finland, Germany, Latvia, Netherlands, Poland, Russia, Slovakia, South Africa, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026