UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000577
Receipt No. R000000691
Scientific Title A three-way crossover clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers
Date of disclosure of the study information 2007/02/01
Last modified on 2016/04/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A three-way crossover clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers
Acronym Clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil
Scientific Title A three-way crossover clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers
Scientific Title:Acronym Clinical pharmacological study to evaluate a drug interaction on P-gp at Blood Brain Barrier between histamine H1 receptor antagonist Ebastine and P-gp inhibitor Verapamil
Region
Japan

Condition
Condition healthy Japanese male volunteers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate a drug interaction on P-gp at Blood Brain Barrie in healthy Japanese male volunteers. A three-way crossover with more than a 6-day washout period between study sessions is planed. Three study medication group are as follows; E10 group: oral single dose of Ebastin, histamine H1 receptor antagonist, 10 mg, E20 group: oral single dose of Ebastin 20 mg and EV group: oral single dose of Ebastin 10 mg and oral single dose of Verapamil, P-gp inhibitor, at 3 hours after Ebastin dosing. Sedative side effect of Ebastin is measured with both saccadic eye movement analysis as a subjective evaluation and Visual Analogue Scale (VAS) as an objective evaluation. And PK/PD analysis is also performed.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Saccadic eye movement peak velocity
Key secondary outcomes Other saccadic eve movement parameters (latency)
Visual analogue scale alertness score
Plasma concentration of Carabastine

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ebastin 10 mg single oral dose
Interventions/Control_2 Ebastin 20 mg single oral dose
Interventions/Control_3 Ebastin 10 mg single oral dose +Verapamil 80 mg single oral dose
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria 1.Healthy Japanese male volunteer
2.Age from 20<= <40
3.Subjects who can report self condition
4.Without clinically significant abnormalities in a series of screening examination
5.Written informed consent
Key exclusion criteria 1.Any clinically significant history of drug abuse, alcoholic abuse, heart, liver, kidney, lung, and blood disease etc. thought to be not eligible to participate in the study
2.Subjects known to treated with medicine which has a sedative effect or an antihistaminic agents
3.Subjects who can not abstaine from smoking during study period
4. Subjects who have the 1st deg. AV block on their ECG examination at screening visit.
5. Subjects who have any clinically significant abnormalities on their ECG examination at screening visit.
6.Any drug allergy history
7.Subjects who is using excessive alcohol regularly (cannot keep abstinence for study period)
8.Perticipation in any clinical trial within 4 months
9.Donation of more than 200mL blood within 3 months
10.Any use of drugs in the 2 weeks prior to study drug administration
11.Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki UCHIDA MD.,PhD
Organization Showa University School of Medicine
Division name Second department of Pharmacology
Zip code
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL 03-3784-8128
Email nuchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki UCHIDA MD.,PhD
Organization Showa University School of Medicine
Division name Second department of Pharmacology
Zip code
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL 03-3784-8128
Homepage URL
Email nuchida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine Second department of Pharmacology
Institute
Department

Funding Source
Organization The Special Subsidies in Subsidies for ordinary expenses of private schools from the Ministry of Education, Culture, Sports, Science and Technology in 2006.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Yakusen-kai Kannondai Clinic
Name of secondary funder(s) Not applicable

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Cmax and AUC of plasma Carebastine, active metabolite of Ebastine, in E20 were about 2-fold higher than those in E10. The amount of increased of Cmax and AUC was proportionateto dose escalation. The pharmacokinetic profiles of plasma carebastine in EV was similar to those in E10, not co-administered P-gp inhibitor verapamil. That suggested verapamil 80 mg did not affect on ebastine and carebastine PK.
No statistically significant change was observed in SPV after dose of ebastine in all E10, E20 and EV groups. And VAS, as a parameter subjective evaluation, was also no significant change in all groups.
These results suggested that clinically significant sedative side effect would not occur after dose of the 2nd generation of anti-histamine Ebastine, even though P-gp at BBB was inhibited by verapamil co-administered.

Chinese Journal of Pharmacology and Toxicology. 21(4) p.335, 2007
Jpn. J Clin. Pharmacol. Ther., 38(Suppl): S244, 2007  
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 05 Month 01 Day
Date trial data considered complete
2007 Year 05 Month 01 Day
Date analysis concluded
2007 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 01 Month 19 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000691

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.