DermatitisPhase 1NCT02447393
Phase 1 Study of Levocetirizine
A Phase 1 study testing levocetirizine and cetirizine in people with Dermatitis, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine. Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- levocetirizine and cetirizine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 18 Mar 2008to 30 Apr 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
- Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.
- Non-smokers (at least 6 months).
- Clinical laboratory tests data obtained at screening meet the following:
- AST(GOT), ALT(GPT), total-bilirubin, BUN, creatinine, uric acid,: below the upper normal range
- Normal 12-lead EGC finding at screening; QTc interval <450msec
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- The subject has an allergy for any drug or idiosyncrasy.
- The subject has a history of allergic rhinitis.
- The subject has a history or presence of clinically significant gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or elimination of drugs.
- The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
- The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
Show all 11Show fewer
- The subject has a history or current conditions of drug abuse or alcoholism.
- History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 150mL of wine or 360mL of beer or 45mL of 80 proof distilled spirits).
- The subject is positive for urine drug screening.
- The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
- The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Randomized, Single Oral Dose Study to Compare the Oral Disposition of Levocetirizine When Given Alone (5mg) or as the Racemate (Cetirizine 10mg), and to Investigate the Safety and Tolerability and the Pharmacokinetics of Levocetirizine and Cetirizine, Following a Single Dose in Healthy Japanese Male Subjects
This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.
- Conditions
- Dermatitis
- Being tested
- levocetirizine, cetirizine, placebo
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levocetirizineDrug
levocetirizine
cetirizineDrug
cetiridine
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| levocetirizine | Other | Study Drug Receives: Drug: levocetirizine |
| cetirizine | Other | Study Drug Receives: Drug: cetirizine |
| placebo | Other | Study Drug Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-48 of levocetirizine
Area Under the time-concentlation curve
Measured: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
Cmax of levocetirizine
maximum concentration
Measured: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
Secondary outcomes (4)
Number of Adverse events
Measured: predose,1,24 48 hours post-dose
Changes in clinical laboratory tests
Measured: predose,24,48 hours post-dose
Changes in vital signs
Measured: predose,1,24,48 hours post-dose
Changes in 12-lead ECG.
Measured: predose,1,24,48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start18 Mar 2008
- Primary completion30 Apr 2008
- Study completion30 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT02447393
- Sponsor's protocol ID
- 111580
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2011
- Last updated
- 3 Aug 2017
- Results posted
- No
Publications
Hiroko Ino, Shigeru Nohda, Shuji Miki, Kastutoshi Hara, Toshiyasu Hirama. Comparison of levocetirizine pharmacokinetics, following a single dose of levocetirizine alone or as cetirizine in Japanese healthy male volunteers . [Jpn J Clin Pharmacol Therapeut]. 2010;41(6):309.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized, Single Oral Dose Study to Compare the Oral Disposition of Levocetirizine When Given Alone (5mg) or as the Racemate (Cetirizine 10mg), and to Investigate the Safety and Tolerability and the Pharmacokinetics of Levocetirizine and Cetirizine, Following a Single Dose in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT02447393
- Acronym / sponsor ID
- 111580
- Conditions
- Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2008 (actual)
- Primary completion
- 30 Apr 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 18 May 2015 (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 is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| levocetirizine | Other | Drug: levocetirizineStudy Drug |
| cetirizine | Other | Drug: cetirizineStudy Drug |
| placebo | Other | Drug: placeboStudy Drug |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
- Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.
- Non-smokers (at least 6 months).
- Clinical laboratory tests data obtained at screening meet the following:
- AST(GOT), ALT(GPT), total-bilirubin, BUN, creatinine, uric acid,: below the upper normal range
Key exclusion criteria (11 listed)
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- The subject has an allergy for any drug or idiosyncrasy.
- The subject has a history of allergic rhinitis.
- The subject has a history or presence of clinically significant gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or elimination of drugs.
- The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
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 |
|---|---|---|
| levocetirizinelevocetirizine | Drug | levocetirizine |
| cetirizinecetiridine | Drug | cetirizine |
| placeboplacebo | Drug | placebo |
Primary outcome
AUC0-48 of levocetirizine
Time frame: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
Area Under the time-concentlation curve
Cmax of levocetirizine
Time frame: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose
maximum concentration
4 secondary outcomes
Number of Adverse events
Time frame: predose,1,24 48 hours post-dose
Changes in clinical laboratory tests
Time frame: predose,24,48 hours post-dose
Changes in vital signs
Time frame: predose,1,24,48 hours post-dose
Changes in 12-lead ECG.
Time frame: predose,1,24,48 hours post-dose
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 3 Aug 2017.
- BackgroundHiroko Ino, Shigeru Nohda, Shuji Miki, Kastutoshi Hara, Toshiyasu Hirama. Comparison of levocetirizine pharmacokinetics, following a single dose of levocetirizine alone or as cetirizine in Japanese healthy male volunteers . [Jpn J Clin Pharmacol Therapeut]. 2010;41(6):309.
- Results for study 111580 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Dermatitis
RecruitingPhase 2
A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis
Atopic Dermatitis
Active, not recruitingPhase 2
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 2
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis
Dermatitis Atopic
Active, not recruitingPhase 2
A Study Evaluating APG777 in Atopic Dermatitis
Atopic Dermatitis
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 levocetirizine and cetirizine in people with Dermatitis, 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 7 inclusion and 11 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 3 Aug 2017. 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?
AUC0-48 of levocetirizine (time frame: predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447393, which also lists 1 linked publication.
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 3 Aug 2017.