Phase 1 Study of Levocetirizine

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02447393
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 14.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis	Drug: levocetirizine; Drug: cetirizine; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 18, 2008
• Actual Primary Completion Date: Apr 30, 2008
• Actual Study Completion Date: Apr 30, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: levocetirizine Study Drug	Drug: levocetirizine; levocetirizine
Other: cetirizine Study Drug	Drug: cetirizine; cetiridine
Other: placebo Study Drug	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. AUC0-48 of levocetirizine [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

2. Cmax of levocetirizine [predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose]

   maximum concentration

Secondary Outcome Measures

1. Number of Adverse events [predose,1,24 48 hours post-dose]

2. Changes in clinical laboratory tests [predose,24,48 hours post-dose]

3. Changes in vital signs [predose,1,24,48 hours post-dose]

4. Changes in 12-lead ECG. [predose,1,24,48 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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.

2. Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.

3. Non-smokers (at least 6 months).

4. 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

1. Normal 12-lead EGC finding at screening; QTc interval <450msec

2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. 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.

2. The subject has an allergy for any drug or idiosyncrasy.

3. The subject has a history of allergic rhinitis.

4. 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.

5. 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.

6. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.

7. The subject has a history or current conditions of drug abuse or alcoholism.

8. 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).

9. The subject is positive for urine drug screening.

10. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.

11. The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Kagoshima		Japan	890-0081

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02447393
• Other Study ID Numbers: 111580
• First Posted: May 18, 2015
• Last Update Posted: Aug 3, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Dermatitis; Cetirizine; Levocetirizine

Study Results

No Results Posted as of Aug 3, 2017