Back to results

Phase 1 Study of Levocetirizine

Primary Purpose

Dermatitis

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

levocetirizine

cetirizine

placebo

About this trial

This is an interventional prevention trial for Dermatitis

Eligibility Criteria

20 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

levocetirizine

cetirizine

placebo

Arm Description

Study Drug

Outcomes

Primary Outcome Measures

AUC0-48 of levocetirizine

Area Under the time-concentlation curve

Cmax of levocetirizine

maximum concentration

Secondary Outcome Measures

Number of Adverse events

Changes in clinical laboratory tests

Changes in vital signs

Changes in 12-lead ECG.

Full Information

NCT ID

NCT02447393

First Posted

June 23, 2011

Last Updated

August 1, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02447393

Brief Title

Phase 1 Study of Levocetirizine

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 18, 2008 (Actual)

Primary Completion Date

April 30, 2008 (Actual)

Study Completion Date

April 30, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

levocetirizine

Arm Type

Other

Arm Description

Study Drug

Arm Title

cetirizine

Arm Type

Other

Arm Description

Study Drug

Arm Title

placebo

Arm Type

Other

Arm Description

Study Drug

Intervention Type

Drug

Intervention Name(s)

levocetirizine

Intervention Description

levocetirizine

Intervention Type

Drug

Intervention Name(s)

cetirizine

Intervention Description

cetiridine

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

AUC0-48 of levocetirizine

Description

Area Under the time-concentlation curve

Time Frame

predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose

Title

Cmax of levocetirizine

Description

maximum concentration

Time Frame

predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose

Secondary Outcome Measure Information:

Title

Number of Adverse events

Time Frame

predose,1,24 48 hours post-dose

Title

Changes in clinical laboratory tests

Time Frame

predose,24,48 hours post-dose

Title

Changes in vital signs

Time Frame

predose,1,24,48 hours post-dose

Title

Changes in 12-lead ECG.

Time Frame

predose,1,24,48 hours post-dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

890-0081

Country

Japan

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

Learn more about this trial

Phase 1 Study of Levocetirizine

We'll reach out to this number within 24 hrs