Last updated: 11/03/2018 00:54:30

Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

GSK study ID
104689
See study documents
Clinicaltrials.gov ID
NCT00343278
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients-
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Valaciclovir Hydrochloride
    • Enrollment:
    18
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Virus Diseases
    Product
    valaciclovir
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to August 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    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.
    Inclusion and exclusion criteria
    Inclusion 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).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-13-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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