Herpes LabialisPhase 1NCT00711776
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
A Phase 1 study testing New formulation and Current formulation in people with Herpes Labialis, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- New formulation and Current formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- 10 Apr 2008to 17 Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese adult males between 20 and 55 years of age, inclusive.
- Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.
- Bodyweight >50 kg and body mass index (BMI) between 18.5 and 28.0 at screening.
- Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Baseline QTc interval <450 msec.
- Non-smoker or ex-smoker having ceased smoking for at least 6 months.
- Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.
- The subject is able to attend all visits and complete the study.
Who cannot join
- Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
- Positive for urine drug at screening.
- Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
- Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
- History of drug abuse, or current conditions of drug abuse or alcoholism.
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- Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first application of study medication.
- Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
- History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
- The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
- At the part obtaining keratinized layer, having exanthem, pigment abnormality, the skin symptoms such as wounds and/or an excessive sunburn.
- History of clinically significant itching, erythema and/or rash by any paster.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -
This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
- Conditions
- Herpes Labialis
- Being tested
- New formulation, Current formulation
- Keywords
- Aciclovir cream 5%, Volunteer, Japanese, Male, Bioequivalence
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New formulationDrug
New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
Current formulationDrug
Current formulation of Aciclovir Cream 5% in Japan
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving new formulation in blank test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: New formulation |
| Subjects receiving current formulation in blank test group | Active comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: Current formulation |
| Subjects receiving new formulation in pre-test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: New formulation |
| Subjects receiving current formulation in pre-test group | Active comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: Current formulation |
| Subjects receiving new formulation in main-test group | Experimental | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: New formulation |
| Subjects receiving current formulation in main-test group | Active comparator | Eligible subjects will receive acyclovir cream 5 % following single topical application. Receives: Drug: Current formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
Measured: One day
Secondary outcomes (1)
To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study start10 Apr 2008
- Primary completion17 Aug 2008
- Study completion17 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711776
- Sponsor's protocol ID
- ZVC111449
- Status last verified
- Aug 2018
- First submitted
- 3 Jul 2008
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -
- ClinicalTrials.gov ID
- NCT00711776
- Acronym / sponsor ID
- ZVC111449
- Conditions
- Herpes Labialis
- Keywords
- Aciclovir cream 5%, Volunteer, Japanese, Male, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2008 (actual)
- Primary completion
- 17 Aug 2008 (actual)
- Study completion
- 17 Aug 2008 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving new formulation in blank test group | Experimental | Drug: New formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in blank test group | Active comparator | Drug: Current formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving new formulation in pre-test group | Experimental | Drug: New formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in pre-test group | Active comparator | Drug: Current formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving new formulation in main-test group | Experimental | Drug: New formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in main-test group | Active comparator | Drug: Current formulationEligible subjects will receive acyclovir cream 5 % following single topical application. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy Japanese adult males between 20 and 55 years of age, inclusive.
- Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.
- Bodyweight >50 kg and body mass index (BMI) between 18.5 and 28.0 at screening.
- Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Baseline QTc interval <450 msec.
Key exclusion criteria (12 listed)
- Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
- Positive for urine drug at screening.
- Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
- Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New formulationNew formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan | Drug | Subjects receiving new formulation in blank test group, Subjects receiving new formulation in main-test group, Subjects receiving new formulation in pre-test group |
| Current formulationCurrent formulation of Aciclovir Cream 5% in Japan | Drug | Subjects receiving current formulation in blank test group, Subjects receiving current formulation in main-test group, Subjects receiving current formulation in pre-test group |
Primary outcome
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
Time frame: One day
1 secondary outcome
To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Results for study ZVC111449 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing New formulation and Current formulation in people with Herpes Labialis, run by GlaxoSmithKline at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.