UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033695 |
|---|---|
| Receipt number | R000038418 |
| Scientific Title | OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF RIFAMPICIN ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B |
| Date of disclosure of the study information | 2018/08/09 |
| Last modified on | 2018/08/09 14:51:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF RIFAMPICIN ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B
Acronym
OATP endogenous substrate-interaction study
Scientific Title
OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF RIFAMPICIN ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B
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 OATP1B endogenous substrates, statins (atorvastatin, pitavastatin, rosuvastatin and valsartan) and rifampicin via hepatic OATP1B in Japanese healthy male adults
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of coproporphyrins, total and direct bilirubin, bile acids (including glucuronide and sulfate conjugates), and 7a-hydroxy-4-cholesten-3-one, effect of the administration of rifampicin
Plasma concentrations of atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin, and their metabolites, effect of the coadministration of rifampicin, pharmacokinetic parameters
Key secondary outcomes
Effect of genetic polymorphisms of OATP1B1 and other transporters and metabolizing enzymes related to the disposition of the probe drugs and endogenous substrates
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
baseline (day0), day 1 Drug administration (semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (150 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (300 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)-> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (600 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)
Interventions/Control_2
baseline (day0), day 1 Drug administration (semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (300 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) -> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (150 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)-> (over 1week for washout) -> Drug administration(clinical dose of rifampicin (600 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)
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
1.a history of hypersensitivity to atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin
2.lactose intolerance
3.hypotension (systolic blood pressure <90 mmHg) or hypertension (systolic blood pressure >160 mmHg)
4.donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs
5.a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia
6.known to have Gilberts Disease, and/or Rotor syndrome
7.confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator
8.a clinically severe disease within 30 days before administration of study drugs
9.took drugs, health food including St. Johns wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study
10.smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period
11.took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with prohibition of taking them until the day of discharge in each study period
12.tested positive in an alcohol breath test/urine drug test at screening
13.cannot discontinue the use of drugs other than study drugs from 2 weeks before administration of study drugs until the study completion
14.positive to HBs antigens, HCV antibodies, or HIV antigens/antibodies
15.judged inappropriate by the investigator or subinvestigator
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 | Hiroyuki Kusuhara |
Organization
The University of Tokyo
Division name
Graduate School of Pharmaceutical Sciences
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-5841-4770
Homepage URL
kusuhara@mol.f.u-tokyo.ac.jp
Sponsor or person
Institute
P-One Clinic,Keikokai Medical Corp.
Institute
Department
Personal name
Funding Source
Organization
Pfizer
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
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
医療法人社団慶幸会 ピーワンクリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 09 | 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
| 2018 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038418
