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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011278
Receipt No. 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

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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
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 Trial Management Division
Zip code
Address
TEL 042-625-5216
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 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
URL(English) https://upload.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


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