A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00297206

Collaborator

(none)

Enrollment

Locations

Arms

49.1

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Drug: Valaciclovir	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

Actual Study Start Date :

Jan 25, 2003

Actual Primary Completion Date :

Feb 28, 2007

Actual Study Completion Date :

Feb 28, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Subjects in the age group of 2 to less than 6 years will be included	Drug: Valaciclovir Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 2 Subjects in the age group of 1 to less than 2 years will be included	Drug: Valaciclovir Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 3 Subjects in the age group of 6 months to less than 1 year will be included	Drug: Valaciclovir Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 4 Subjects in the age group of 3 months to less than 6 months will be included	Drug: Valaciclovir Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 5 Subjects in the age group of 1 month to less than 3 months will be included	Drug: Valaciclovir Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.

Outcome Measures

Primary Outcome Measures

Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose. [0.5, 1, 2, 4 and 6 hours]

Secondary Outcome Measures

Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication. [Up to Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Subjects who have a current herpes virus infection.
Have neonatally acquired herpes at risk of potential recurrence.
Immunocompromised or cancer patients at risk for development of a herpes virus infection.

Exclusion criteria:

Hypersensitivity to antiherpetic medications.
Impaired hepatic or renal function.
Show presence of other serious or unstable underlying disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35233
2	GSK Investigational Site	Little Rock	Arkansas	United States	72202
3	GSK Investigational Site	San Diego	California	United States	92123
4	GSK Investigational Site	Jacksonville	Florida	United States	32209
5	GSK Investigational Site	Lexington	Kentucky	United States	40503
6	GSK Investigational Site	Louisville	Kentucky	United States	40202
7	GSK Investigational Site	New Orleans	Louisiana	United States	70112
8	GSK Investigational Site	Durham	North Carolina	United States	27705
9	GSK Investigational Site	Cincinnati	Ohio	United States	45229
10	GSK Investigational Site	Galveston	Texas	United States	77555-0653
11	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7580206
12	GSK Investigational Site	Brits		South Africa	2000
13	GSK Investigational Site	George		South Africa	6529

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00297206

Other Study ID Numbers:

HS210914

First Posted:

Feb 28, 2006

Last Update Posted:

Sep 11, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus

Additional relevant MeSH terms:

Herpes Simplex

Valacyclovir

Study Results

No Results Posted as of Sep 11, 2017