UMIN-CTR Clinical Trial

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

Neurosis, somnipathy

Classification by specialty

Neurology	Psychosomatic Internal Medicine	Adult

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

P-One Clinic, Keikokai Medical Corp

Institute

Department

Personal name

Organization

P-One Clinic, Keikokai Medical Corp

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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