Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00343278

First received: June 21, 2006

Last updated: April 13, 2015

Last verified: April 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Virus Diseases	Drug: Valaciclovir Hydrochloride	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Valacyclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

- The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood

Secondary Outcome Measures:

- Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests)


Estimated Enrollment:	18
Study Start Date:	July 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Japanese subjects with chronic renal failure undergoing hemodialysis regularly three times a week for at least 12 weeks prior to the start of the study.

Exclusion criteria:

Subjects with current alcohol dependence.
Subjects with gastrointestinal dysfunction that may affect drug absorption.
Subjects who have received an organ transplant (However, subjects with a corneal transplant or any other organ transplant that may not affect the objectives of the study will be eligible for inclusion in this study).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343278

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00343278 History of Changes
Other Study ID Numbers:	104689
Study First Received:	June 21, 2006
Last Updated:	April 13, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:


Valaciclovir Hydrochloride hemodialysis patient ALDH pharmacokinetics Japanese

Additional relevant MeSH terms:


Virus Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 27, 2016

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