UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029539 |
|---|---|
| Receipt number | R000033749 |
| Scientific Title | Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adults |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2021/04/16 09:30:00 |
* 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
Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adults
Acronym
Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adults
Scientific Title
Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adults
Scientific Title:Acronym
Comparative study of drug interaction with CYP2C19 substrate by Vonoprazan and Esomeprazole in healthy adults
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Using esomeprazole as a comparative control, we aim to quantitatively analyze drug interactions with Vonoprazan CYP 2C 19 substrate and to ensure safety when using Vonoprazan for drug treatment.
In addition, when drug interaction by these inhibitors is observed, endogenous metabolites which change with administration of inhibitor are identified.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Concentration of esomeprazole, Vonoprazan in plasma
Plasma and urinary concentrations of atovaquone / cycloguanil
Key secondary outcomes
endogenous metabolites which change with administration of inhibitor are identified.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Phase1: Baseline data is obtained by orally administering Atobacon proguanil combination tablet.
Phase2: Inhibitor 1 Esomeprazole magnesium hydrate 20 mg is continuously administered orally for 5 consecutive days, and only the 5 th day is orally administered with Phase1 study drug.
Phase3: inhibitor 2 Vonoprazan fumarate 20 mg is continuously administered orally for 5 consecutive days, and only the 5 th day is orally administered with Phase I study drug.
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
none
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ryokan funakoshi |
Organization
Kameda Medical Center
Division name
Pharmacy
Zip code
Address
929Higashi-cho,Kamogawa City,Chiba
TEL
04-7099-1274
funakoshi.ryokan@kameda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ryokan funakoshi |
Organization
Kameda Medical Center
Division name
Pharmacy
Zip code
Address
929Higashi-cho,Kamogawa City,Chiba
TEL
04-7099-1274
Homepage URL
funakoshi.ryokan@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
ピーワンクリニック（東京都）、東京大学（東京都）、武蔵野大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
