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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011279
Receipt No. R000013192
Scientific Title Independent study: Researching drug-drug interaction bitween etizolam and itraconazole
Date of disclosure of the study information 2013/07/26
Last modified on 2013/07/26

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Basic information
Public title Independent study: Researching drug-drug interaction bitween etizolam and itraconazole
Acronym Independent clinical study (University of Tokyo)
Scientific Title Independent study: Researching drug-drug interaction bitween etizolam and itraconazole
Scientific Title:Acronym Independent clinical study (University of Tokyo)
Region
Japan

Condition
Condition Neurosis, somnipathy
Classification by specialty
Neurology Psychosomatic Internal Medicine Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Compare the drug-drug interaction of etizolam and itraconazole between poor metabolizers and extensive metabolizers of CYP2C19 and factually verify the difference
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Verify the effect of itraconazole on the pharmacokinetics of etizolam in poor metabolizers of CYP2C19 and compare with extensive metabolizers
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Gene
Interventions/Control_1 Extensive metabolizers of CYP2C19
Interventions/Control_2 Poor metabolizers of CYP2C19
Interventions/Control_3
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
35 years-old >=
Gender Male
Key inclusion criteria a) Healthy adult male aged 20-35.
b) Judged by the doctor to be appropriate as a subject, based on clinical testing and a physical examination at the time of screening and medical history.
4) Body mass index over 18.5 and under 24.9 inclusive at the time of screening.
5) The subject is able to understand and abide by the study protocol, and is willing to provide voluntary consent in writing.
Key exclusion criteria a) Has hypotension (blood pressure of less than 100 mmHg during systole), hypertension (blood pressure of 140 mmHg or higher during systole) or diabetes (HbA1c NGSP 6.5% or higher).
b) Has donated or lost over 200 ml (1 unit) of blood within four weeks prior to study drug administration or 400 ml (2 units) within 3 months, or is anemic (less than Hb 12 g/dl).
c) Has a serious neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, digestive tract (including digestive tract disorders thought to impact trial drug absorption), respiratory, or metabolic disease in their medical history or as a concomitant condition.
d) A clinically serious abnormality has been found by the principal investigator or one of the subinvestigators in the clinical test values, ECG or physical examination.
e) Had a clinically serious illness within 30 days prior to study drug administration.
f) Has used some sort of health food, grapefruit (including food containing it), or medical product within seven days prior to study drug administration or will use it during the study period.
g) Has smoked tobacco or ingested nicotine within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period.
h) Cannot abide by the ban on caffeine and alcohol during the study period.
i) Tested positive for a specific abused substance in the urine drug test at the screening.
j) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens.
15) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.
Target sample size 16

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Dr. Kenichi Furihata
Organization P-One Clinic, Keikokai Medical Corp
Division name Clinic Director
Zip code
Address View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization P-One Clinic, Keikokai Medical Corp
Division name Clinical Trial Management Division
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute P-One Clinic, Keikokai Medical Corp
Institute
Department

Funding Source
Organization P-One Clinic, Keikokai Medical Corp
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2013 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2013 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013192

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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