Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Primary Purpose
Virus Diseases
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Valaciclovir Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Virus Diseases focused on measuring Valaciclovir Hydrochloride, hemodialysis patient, ALDH, pharmacokinetics, Japanese
Eligibility 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).
Sites / Locations
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343278
Brief Title
Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Official Title
Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus Diseases
Keywords
Valaciclovir Hydrochloride, hemodialysis patient, ALDH, pharmacokinetics, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valaciclovir Hydrochloride
Primary Outcome Measure Information:
Title
- The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood
Secondary Outcome Measure Information:
Title
- Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
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Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
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