UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CYP3A activity during nontuberculous mycobacterium infection
Title of the study (Brief title)	CYP3A activity during nontuberculous mycobacterium infection
Region	Japan

Condition
Condition	Nontuberculous Mycobacterial Lung Disease
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine CYP3A activity during nontuberculous mycobacterium infection.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CYP3A activity
Key secondary outcomes	Pharmacokinetics, Safety

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	midazolam 1mg
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged 20 years or older who treat nontuberculous mycobacterium infection using rifampicin and clarithromycin. 2) Patients who do not have drug allergy or idiosyncrasy. 3) Patients who do not have a history of drug dependence, alcohol dependence, etc. 4) Patients who can obtain written consent.
Key exclusion criteria	1) The history of drug hypersensitivity. 2) The presence of severe renal or liver dysfunction. 3) Patients who are unable to continue taking medicine.
Target sample size	20

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu university school of medicine
Division name	Second division, depertment of internal medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan.
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Shinpei Kato
Organization	Hamamatsu university school of medicine
Division name	Second division, depertment of internal medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2263
Homepage URL	http://hamamatsu-lung.com/study.html
Email	skato@hama-med.ac.jp

Sponsor
Institute	Hamamatsu university school of medicine Second division, depertment of internal medicine
Institute
Department

Funding Source
Organization	Hamamatsu university school of medicine Second division, depertment of internal medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Respiratory meidicine, National hospital organization Tenryu hospital Department of clinical pharmacology and therapeutics, Hamamatsu university school of medicine
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	浜松医科大学附属病院（静岡県），国立病院機構天竜病院（静岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 15 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	2017 Year 05 Month 11 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031187