A Modified Case Control Study To Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure To Lapaquistat Acetate
Conditions
Interventions
Product Name: Tak 475 (lapaquistat acetate)
Product Code: Tak475
Pharmaceutical Form: Tablet
INN or Proposed INN: Lapaquistat Acetate
Current Sponsor code: TAK-475
Concentration unit: mg milligram(s)
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must be capable of complying with the protocol and has signed the informed consent document prior to undergoing any study-related procedures. 2. The subject has experienced ALT =5×ULN or concurrent elevation of ALT =3×ULN and bilirubin =2×ULN while participating in lapaquistat acetate clinical studies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the genetic contribution to the mechanism of lapaquistat acetate induced hepatic abnormalities.;Secondary Objective: ;Primary end point(s): Whole genome scanning using the Illumina 1M chip. The Illumina 1M chip can measure about 1,000,000 single-nucleotide polymorphisms (SNPs) and 14,000 copy number variation regions. Whole genome scanning using the Affymetrix 500K array chip. The Affymetrix 500K array can measure about 500,000 SNPs. Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array. The Affymetrix DMETTM Plus chip can measure 1936 drug disposition markers in 225 genes that have been associated with drug absorption, distribution, metabolism, and excretion. | — |
Countries
Czech Republic, Finland, Germany, Latvia, Netherlands, United Kingdom
Outcome results
None listed