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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024790
Receipt No. R000016999
Scientific Title Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
Date of disclosure of the study information 2016/11/10
Last modified on 2016/11/10

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Basic information
Public title Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
Acronym Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
Scientific Title Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
Scientific Title:Acronym Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
Region
Japan

Condition
Condition Healthy volunteers (Japanese male)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the quantitative contributions of OATPs and CYP3A4 as determinants of the pharmacokinetics of repaglinide, clarithromycin, bosentan, simeprevir and darunavir in Japanese healthy male adults
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the quantitative contributions of OATPs and CYP3A4 as determinants of the pharmacokinetics of repaglinide, clarithromycin, bosentan, simeprevir and darunavir in Japanese healthy male adults
Key secondary outcomes Genetic polymorphisms of pharmacokinetics-related genes to modify the pharmacokinetics of repaglinide, clarithromycin, bosentan, simeprevir and darunavir
Search for the endogenous biomarkers of metabolic enzymes and transporters by metabolomic analysis of endogenous compounds in the absence and presence of rifampicin or itraconazole

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Drug administration(semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin,and semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam) -> (over 1week for washout) -> Drug administration (clinical dose of itraconazole, and semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam)
Interventions/Control_2
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
40 years-old >=
Gender Male
Key inclusion criteria a) Japanese male subjects at the age of 20-40 at the timing of informed consent
b) Person who is judged as an appropriate subject for this clinical study by doctors based on the previous medical history and the results of clinical test at the screening
c) BMI of subject should be in the range of 18.5 and 25 at the screening.
d) person who can understand and follow the clinical study plan and give us a written informed consent based on the free will
Key exclusion criteria a) Subjects who have any hypersensitivity to repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam, rifampicin, itraconazole.
b) Subjects who is suffering from acute narrow-angle glaucoma.
c) Subjects who is suffering from hypotension( systolic blood pressure < 100mmHg ), hypertension (systolic blood pressure > 140mmHg), diabetes and anemia ( Hb < 12.0g/dL ) at the timing of the screening.
d) Subjects who donated or lost over 200 mL (1 unit ) of blood in the past 4weeks or over 400mL (2 units) of blood in the past 3months.
e) Subjects who suffer/suffered from severe nervous disease, celebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including disease which is expected to affect the absorption of test drugs), respiratory disease and metabolic disease.
f) Subjects who is confirmed to have severe clinical abnormalities judged by the diagnostics or physical examination by chief doctor or associate doctors.
g) Subjects who is suffering from clinically severe diseases within 30 days before the administration of test drugs.
h) Subjects who take medicine, health foods including St. John's wort, foods or drinks containing greapefruit, orange, and apple, and supplements, and cannot stop taking these during this clinical study.
i) Subjects who smoke or take nicotine within 30 days before the administration of test drugs, and cannot stop smoking during this clinical study
j) Subjects who take foods/drinks containing alcohol or caffeine one day before the date of hospital admission, and cannot stop taking these until the final day of this study.
k) Subjects whose results of alcohol breath test or uninary drug screening are positive at the timing of screening.
l) Subjects whose results of any tests of serological reaction for HBs antigen, HCV antibody or HIV antigen and antibody are positive
m) Subjects who is not suitable for this study judged by chief doctor or associte doctors.
Target sample size 8

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 Chairman
Zip code
Address View Tower Hachioji 4F Yokamachi Hachioji City,Tokyo,Japan 192-0071
TEL 042-625-5216
Email furihata@p1-clinic.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dr. Kenichi Furihata
Organization P-One Clinic,Keikokai Medical Corp.
Division name Chairman
Zip code
Address View Tower Hachioji 4F Yokamachi Hachioji City,Tokyo,Japan 192-0071
TEL 042-625-5216
Homepage URL
Email furihata@p1-clinic.or.jp

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

Funding Source
Organization P-One Clinic,Keikokai Medical Corp.
Sugiyama Laboratory,RIKEN Innovation Center,RIKEN Research Cluster for Innovation.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Sugiyama Laboratory,RIKEN Innovation Center,RIKEN Research Cluster for Innovation.
Department of Molecular Pharmacokinetics,Graduate School of Pharmaceutical Sciences,The University of Tokyo.
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 医療法人社団慶幸会 ピーワンクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 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
2016 Year 11 Month 10 Day
Last modified on
2016 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016999

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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