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

Takeda

Status: Completed

Conditions: Toxicity

Treatments: Other: Pharmacogenomic whole blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT00890448

U1111-1112-3768 (Registry Identifier)

DOH-27-0410-2857 (Registry Identifier)

TAK-475_310

2008-006906-41 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Volunteers: No 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

Trial design

66 participants in 1 patient group

Lapaquistat acetate participants

Treatment:

Other: Pharmacogenomic whole blood sampling