UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000577 |
|---|---|
| Receipt number | 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 12:02:33 |
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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
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
nuchida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine Second department of Pharmacology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000691
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| Registered date | File name |
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