Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343278
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2006-06-21
Brief Title:
Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None