UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Title of the study (Brief title)	Drug interaction study between Midazolam and Anchusan.
Region	Japan

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

Objectives
Narrative objectives1	This is a pilot study to investigate the effects of the 7 days Anchusan multiple dose (7.5g/day) on the pharmacokinetics of oral administration of midazolam (7.5mg) in Japanese healthy male subjects. The pharmacodynamic interaction between midazolam and Anchusan will also be investigated by using both objective and subjective evaluation.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The pharmacokinetic parameters of plasma midazolam (AUC(0-10), Cmax, t1/2, tmax)
Key secondary outcomes	1. The sedative action after midazolam oral administration (subjective evaluation: VAS, objective evaluation: simple EEG measurement) 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	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Midazolam single oral administration
Interventions/Control_2	Midazolam single oral administration after 7days Anchusan (7.5g/day) dose
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	20 years-old <=
Age-upper limit	45 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	3

Research contact person
Name of lead principal investigator	Naoki Uchida MD, PhD
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	nuchida@med.showa-u.ac.jp

Public contact
Name of contact person	Naoki Uchida MD, PhD
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	nuchida@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	2011 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 26 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2012 Year 01 Month 01 Day
Date of closure to data entry	2012 Year 06 Month 01 Day
Date trial data considered complete	2012 Year 06 Month 01 Day
Date analysis concluded	2012 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This pilot study was performed in two subjects. No adverse event was observed during the study in all subjects. Mean value of PK parameter of plasma Midazolam are as follows; Pre-dose of Anchu-san Cmax:112.34 ng/mL, AUC:418.94 ng*hr/mL After 7 days Anchu-san dose Cmax:166.85 ng/mL, AUC:528.94 ng*hr/mL No difference was observed in VAS scale between pre- and post- Anchu-san dose. It was suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose. The verification study will be conducted with increased number of study subjects.
Other related information

Management information
Registered date	2011 Year 11 Month 02 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=R000007759