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

NCT ID: NCT00890448

Last Updated: 2012-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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

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Detailed Description

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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

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Toxicity

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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Lapaquistat acetate participants

Pharmacogenomic whole blood sampling

Intervention Type OTHER

10 mL, whole blood, one sample on Visit 2

Interventions

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Pharmacogenomic whole blood sampling

10 mL, whole blood, one sample on Visit 2

Intervention Type OTHER

Other Intervention Names

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TAK-475

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Jacksonville, Florida, United States

Site Status

Jupiter, Florida, United States

Site Status

Idaho Falls, Idaho, United States

Site Status

Richmond, Virginia, United States

Site Status

Córdoba, , Argentina

Site Status

Québec, , Canada

Site Status

Sainte-Foy, , Canada

Site Status

Santiago, , Chile

Site Status

Havírov-Šumbark, , Czechia

Site Status

Oulu, , Finland

Site Status

Nuremberg, , Germany

Site Status

Riga, , Latvia

Site Status

Groningen, , Netherlands

Site Status

Gdansk, , Poland

Site Status

Moscow, , Russia

Site Status

Saratov, , Russia

Site Status

Žilina, , Slovakia

Site Status

Johannesburg, , South Africa

Site Status

Glasgow, Scotland, United Kingdom

Site Status

Countries

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

Other Identifiers

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2008-006906-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1112-3768

Identifier Type: REGISTRY

Identifier Source: secondary_id

DOH-27-0410-2857

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-475_310

Identifier Type: -

Identifier Source: org_study_id

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