UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032266
Receipt No. R000036760
Scientific Title Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human
Date of disclosure of the study information 2018/04/16
Last modified on 2018/10/16

* 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 Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human
Acronym Drug-drug interaction between Selexipag and Clopidogrel
Scientific Title Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human
Scientific Title:Acronym Drug-drug interaction between Selexipag and Clopidogrel
Region
Japan

Condition
Condition pharmacokinetic trial
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to
compare pharmacokinetic of single administration of selesixpag with that of combined medication of selexipag, a substrate of CYP2C8, and clopidogrel, an inhibitor of CYP2C8 actyvity, in adult males.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC 0 to 48hrs and 0 to infinity of Selexipag and MRE 269
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In 1st pharmacokinetic(PK) trial, subjects take selexipag 0.4mg at 0 min, and physicians take blood samples at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours.
Interventions/Control_2 3 days before 2nd PK trial, subjects take clopidgrel 300mg. 2 days and the day before 2nd PK trial, they take clopidgrel 75mg.
In 2nd PK trial, subjects take selexipag 0.4mg at 0 min, and physicians take blood samples at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours.
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

Not applicable
Gender Male
Key inclusion criteria 1 over 20 years-old male
2 subject who has no abnormality of hemglobin value and platelet count
3 subject who has no liver dysfunction, renal dysfunction and disease receiving treatment
4 subject who has no drug allergy and idiosyncrasy
5 subject who has no dependence of drug and alcohol
6 subject who can provide imformed consent
Key exclusion criteria 1 subject who takes medicine 1 week before each 1st and 2nd PK trial
2 subject who has apparent abnormality in advance blood and biochemical examinations
3 subject who were judged to be not eligible in this study by the physician in chrage
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Hakamata
Organization Hamamatsu University School of Medicine
Division name Clinical Pharmacology and Therapeutics
Zip code
Address -20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2385
Email hakamata@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Hakamata
Organization Hamamatsu University School of Medicine
Division name Clinical Pharmacology and Therapeutics
Zip code
Address -20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2385
Homepage URL
Email hakamata@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, Clinical Pharmacology and Therapeutics
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine, Clinical Pharmacology and Therapeutics
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor School of Pharmaceutical Sciences Univercity of shizuoka, Department of Pharmacy Practice and Science
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 浜松医科大学医学部

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 16 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 11 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 04 Month 16 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.