UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human
Title of the study (Brief title)	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	Akio Hakamata
Organization	Hamamatsu University School of Medicine
Division name	Clinical Pharmacology and Therapeutics
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	Akio Hakamata
Organization	Hamamatsu University School of Medicine
Division name	Clinical Pharmacology and Therapeutics
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036760