UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024790
Receipt number 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 16:30:02

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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 or person

Institute

P-One Clinic,Keikokai Medical Corp.

Institute

Department

Personal name



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

Value
https://center6.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