Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted
to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is
predominantly eliminated unchanged in the urine, with a small proportion metabolized to
9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve
aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population
having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is
decreased, thereby leading, in patients with renal impairment, to higher plasma
concentrations of ACV. This pilot study was conducted to investigate potential relationships
between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics
(PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.