UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033749