UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032266 |
|---|---|
| Receipt number | 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 09:16:02 |
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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
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
hakamata@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, Clinical Pharmacology and Therapeutics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036760
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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