UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028684 |
|---|---|
| Receipt number | R000032837 |
| Scientific Title | Study for drug-drug interactions involving hepatic OATPs using its endogenous substrates |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2017/08/16 10:45:04 |
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Basic information
Public title
Study for drug-drug interactions involving hepatic OATPs using its endogenous substrates
Acronym
OATP endogenous substrate-interaction study
Scientific Title
Study for drug-drug interactions involving hepatic OATPs using its endogenous substrates
Scientific Title:Acronym
OATP endogenous substrate-interaction study
Region
| Japan |
Condition
Condition
Healthy volunteers (Japanese male)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Quantitative analysis for interactions between OATP endogenous substrates, statins (atorvastatin, fluvastatin, pitavastatin, and rosuvastatin) and rifampicin via hepatic OATPs in Japanese healthy male adults
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma and urinary concentrations of coproporphyrins, DHEAS, bilirubin and its glucuronides, bile acids (including glucuronide and sulfate conjugates), and 7a-hydroxy-4-cholesten-3-one, effect of the administration of rifampicin
Plasma and urinary concentrations of atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and rifampicin, and their metabolites, effect of the coadministration of rifampicin, pharmacokinetic parameters
Key secondary outcomes
SNPs of drug-metabolizing enzymes and transporters relating pharmacokinetics (OATP1B1, CYP3A4, CYP2C8, CYP2C9)
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 atorvastatin, fluvastatin, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (300 mg), and semi-pharmacological dose of atorvastatin, fluvastatin, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration (clinical dose of rifampicin (600 mg), and semi-pharmacological dose of atorvastatin, fluvastatin, pitavastatin, and rosuvastatin)
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 atorvastatin, fluvastatin, pitavasitatin, rosuvastatin, and rifampicin.
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. Ken-ichi 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
furihata@p1-clinic.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Ken-ichi 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
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, Research Cluster for Innovation, RIKEN
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | Month | 16 | 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
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032837
