Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
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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 |
|---|---|---|
|
Renal Impairment |
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- |
- - The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood
- - 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) |
-
Drug: Valaciclovir Hydrochloride
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00343278
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00343278 History of Changes |
| Other Study ID Numbers: | 104689 |
| Study First Received: | June 21, 2006 |
| Last Updated: | October 5, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by GlaxoSmithKline:
|
Valaciclovir Hydrochloride pharmacokinetics hemodialysis patient Japanese ALDH |
Additional relevant MeSH terms:
|
Acyclovir Valacyclovir Anti-Infective Agents |
Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015