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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029539
Receipt No. 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 2017/10/13

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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
Email 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
Email funakoshi.ryokan@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
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 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
Anticipated trial start date
2017 Year 09 Month 21 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
2017 Year 10 Month 13 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.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


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