UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011279
Receipt number 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 12:12:26

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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

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

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 or person

Institute

P-One Clinic, Keikokai Medical Corp

Institute

Department

Personal name



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

Value
https://center6.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