UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011278
Receipt number R000013189
Scientific Title Independent clinical study: Study of the effect of CYP2C19 genetic polymorphism on drug-drug interaction between tacrolimus and voriconazole in healthy subjects.
Date of disclosure of the study information 2013/07/26
Last modified on 2015/08/12 12:25:07

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Basic information

Public title

Independent clinical study: Study of the effect of CYP2C19 genetic polymorphism on drug-drug interaction between tacrolimus and voriconazole in healthy subjects.

Acronym

Impact of CYP2C19 genotype on drug-drug interaction of voriconazole and tacrolimus.

Scientific Title

Independent clinical study: Study of the effect of CYP2C19 genetic polymorphism on drug-drug interaction between tacrolimus and voriconazole in healthy subjects.

Scientific Title:Acronym

Impact of CYP2C19 genotype on drug-drug interaction of voriconazole and tacrolimus.

Region

Japan


Condition

Condition

Pharmacogenomics

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Clarify the impact of cytochrome P450 (CYP) 2C19 genetic polymorphism on the drug-drug interaction between tacrolimus and voriconazole in healthy subjects

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Variation in the blood concentration of tacrolimus when coadministered with voriconazole and when administered alone in extensive metabolizers (EM), intermediate metabolizers (IM) and poor metabolizers (PM) of CYP2C19

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

3

Purpose of intervention

Treatment

Type of intervention

Gene

Interventions/Control_1

Extensive metabolizers among those with CYP2C19 genetic polymorphism

Interventions/Control_2

Intermediate metabolizers among those with CYP2C19 genetic polymorphism

Interventions/Control_3

Poor metabolizers among those with CYP2C19 genetic polymorphism

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

55 years-old >=

Gender

Male

Key inclusion criteria

1) Over the age of 20 and under the age of 55 inclusive at the time of consent.
2) Body weight 40 kg or above.
3) Judged by the doctor in charge of the trial to be appropriate, based on clinical testing and a physical examination at the time of screening and medical history.
4) Body mass index is over 18.5 and under 24.9 inclusive at the time of the screening.
5) Is willing to provide voluntary consent in writing.

Key exclusion criteria

1) Has a drug allergy to tacrolimus or
voriconazole.
2) Regularly takes some kind of medication.
3) Is anemic (less than Hb 12 g/dL).
4) Has hypotension (blood pressure of less than 100 mmHg during systole) or hypertension (blood pressure of 140 mmHg or higher during systole).
5) Has diabetes (HbA1c (NGSP) 6.5% or higher).
6) Has a serious neurological, cerebrovascular, cardiovascular, respiratory, hepatic, renal, endocrine or metabolic disease.
7) Has a digestive tract disorder of the sort that impacts absorption of drugs taken orally.
8) Has donated or lost over 200 ml (1 unit) of blood within four weeks or 400 ml (2 units) within three months prior to study drug administration.
9) Contracted a clinically serious illness within four weeks prior to study drug administration.
10) Has smoked tobacco (including ingestion of nicotine) within four weeks prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period.
11) Has ingested some sort of nutritional supplement, health food, grapefruit (including food containing it), or medical product within one week prior to study drug administration.
12) Cannot abide by the ban on consumption of caffeine and alcohol starting two days before hospitalization until the follow-up examination.
13) Tested positive for a specific abused substance in the urine drug test at the screening.
14) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens.
15) Anything else that the doctor in charge judges to be disqualifying.

Target sample size

18


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

Trial Management Division

Zip code


Address


TEL

042-625-5216

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 07 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 25 Day

Last follow-up date

2013 Year 07 Month 31 Day

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

2015 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name