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Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 21, 2006
Last updated: April 13, 2015
Last verified: April 2015
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
Intervention Model: Single Group Assignment
Masking: None (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:

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)

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

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).
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Please refer to this study by its identifier: NCT00343278

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00343278     History of Changes
Other Study ID Numbers: 104689
Study First Received: June 21, 2006
Last Updated: April 13, 2015

Keywords provided by GlaxoSmithKline:
Valaciclovir Hydrochloride
hemodialysis patient

Additional relevant MeSH terms:
Virus Diseases
Antiviral Agents
Anti-Infective Agents processed this record on September 19, 2017