UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study to investigate the drug interaction via CYP3A between oral Midazolam administration and short term multiple Anchu-san dose in Japanese male subjects.
Title of the study (Brief title)	Drug interaction study between Midazolam and short term Anchu-san multiple dose.
Region	Japan

Condition
Condition	Japanese healthy male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The pilot study that previously conducted (UMIN ID:000006655) suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam (MDZ) dose. Therefore this study will be conducted to investigate the effects of the short term Anchu-san multiple dose (three times of 2.5g each) on the PK of oral administration of MDZ (7.5mg) in Japanese healthy male subjects. Short term Anchu-san repeated dose will be taken in two different groups that are allocated randomly. In G16 group, MDZ will be administered at 16 hours after the last Anchu-san dose. And MDZ administration will be performed at 2 hours after last Anchu-san in G2 group. The time effect of Anchu-san on MDZ PK in those 2 groups will also be investigated. In addition to these, the pharmacodynamic interaction between midazolam and Anchu-san will also be investigated.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The pharmacokinetics parameter of midazolam in serum (AUC 0-8), Cmax, t1/2, tmax)
Key secondary outcomes	1. The sedative action after midazolam oral administration: VAS 2. Safety assessment (pulse oximeter, vital measurement, adverse event)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Midazolam single oral administration at 2 hours after three times repeated dose of 2.5g Anchu-san
Interventions/Control_2	Midazolam single oral administration at 16 hours after three times repeated dose of 2.5g Anchu-san
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	1) Age: 20 - 45 years old at the time of informed consent 2)Sex: male 3) Subjects are competent to consent, keep the rules of the study and are able to report self condition. 4) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Key exclusion criteria	1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements). 2) Any history for drug allergy 3) Subjects who are taking in too much alcohol (those who cannot maintain the abstains from alcohol during study period) 4) Subjects within three months after the participation to other clinical trials 5) Subjects who are inadequate for enrollment judged by the investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	Takehiko Sanbe MD
Organization	Showa University School of Medicine
Division name	Department of Clinical Pharmacology
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL	03-3784-8128
Email	t-sambe@med.showa-u.ac.jp

Public contact
Name of contact person	Takehiko Sanbe MD
Organization	Showa University School of Medicine
Division name	Department of Clinical Pharmacology
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL	03-3784-8128
Homepage URL
Email	t-sambe@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	昭和大学臨床薬理研究センター（東京都） Showa University Clinical Trial Center for Clinical Pharmacology (Tokyo)

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 29 Day
Anticipated trial start date	2012 Year 07 Month 17 Day
Last follow-up date	2012 Year 10 Month 01 Day
Date of closure to data entry	2012 Year 11 Month 01 Day
Date trial data considered complete	2012 Year 12 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	This study was performed in 12 subjects. No adverse event was observed during the study in all subjects. No pronounced differences on PK parameter of plasma Midazolam between pre- and post dose of Anch-san were observed in both G2 and G16 group. No difference was also observed in VAS scale. It was suggested that 1 day oral Anchu-san administration would not prominently affect on PK of oral Midazolam dose. J. Showa Med Assoc.(in print)
Other related information

Management information
Registered date	2012 Year 06 Month 19 Day
Last modified on	2016 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000009635