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

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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

Email

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


Email

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


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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name