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Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343278
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Virus Diseases Drug: Valaciclovir Hydrochloride Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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-
Study Start Date : July 2005
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. - 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 :
  1. - Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
Valaciclovir Hydrochloride
hemodialysis patient
ALDH
pharmacokinetics
Japanese

Additional relevant MeSH terms:
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents